Trial Outcomes & Findings for Lovastatin in Treating Patients At High Risk of Melanoma (NCT NCT00462280)

NCT ID: NCT00462280

Last Updated: 2014-10-31

Results Overview

The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 80 participants
• Primary outcome timeframe: From baseline up to 24 weeks
• Results posted on: 2014-10-31

Participant Flow

Participant milestones

Measure	Two Matched Nevi Group - Lovastatin Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	One Large Nevi Group - Lovastatin Patients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	One Large Nevi Group - Placebo Patients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Overall Study STARTED	34	32	7	7
Overall Study COMPLETED	24	25	7	4
Overall Study NOT COMPLETED	10	7	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lovastatin in Treating Patients At High Risk of Melanoma

Baseline characteristics by cohort

Measure	Two Matched Nevi Group-Lovastatin n=34 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group-Placebo n=32 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	One Large Nevi Group-Lovastatin n=7 Participants Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	One Large Nevi Group-Placebo n=7 Participants Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Total n=80 Participants Total of all reporting groups
Age, Continuous	42.82 years STANDARD_DEVIATION 10.96 • n=5 Participants	42.16 years STANDARD_DEVIATION 11.28 • n=7 Participants	45.71 years STANDARD_DEVIATION 10.98 • n=5 Participants	36.29 years STANDARD_DEVIATION 11.98 • n=4 Participants	42.24 years STANDARD_DEVIATION 11.16 • n=21 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	45 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	35 Participants n=21 Participants
Region of Enrollment United States	34 participants n=5 Participants	32 participants n=7 Participants	7 participants n=5 Participants	7 participants n=4 Participants	80 participants n=21 Participants

PRIMARY outcome

Timeframe: From baseline up to 24 weeks

Population: Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.

The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=24 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=25 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation	0.50 score Standard Deviation 1.10	-0.12 score Standard Deviation 1.33

PRIMARY outcome

Timeframe: From baseline up to 24 weeks

Population: Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.

The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=24 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=25 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation	0.17 score Standard Deviation 1.81	0.04 score Standard Deviation 1.95

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

From close-up photos of target atypical nevi, lesions will be graded clinically. After unblinding of pre- or post-treatment status for photos, the grading score was as follows: 1= Post-treatment (Post-TX) photo shows a complete resolution of atypia relative to pre-treatment (Pre-TX) photo, 2 = Post-TX photo shows a strong lessening of atypia relative to Pre-TX photo, 3 = Post-TX photo shows a mild lessening of atypia relative to Pre-TX photo, 4 = Post-TX and Pre-TX photos show same degree of atypia, 5 = Pre-TX photo shows a mild lessening of atypia relative to Post-TX photo, 6 = Pre-TX photo shows a strong lessening of atypia relative to Post-TX photo, 7 = Pre-TX photo shows a complete resolution of atypia relative to Post-TX photo. The Wilcoxon rank sum test will be applied to compare the scores for patients treated with placebo vs. those treated with lovastatin.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=20 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=27 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations	4.03 score Standard Deviation 0.26	3.98 score Standard Deviation 0.31

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

Assessed by photos of subjects' back pre and post treatment. These photos will be used to count, by blinded evaluators, the number of nevi on the back pre and post therapy.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=23 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=26 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations Fewer nevi after the treatment	4 pairs of photos	3 pairs of photos
Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations Same number of nevi after treatment	64 pairs of photos	67 pairs of photos
Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations More nevi after the treatment	1 pairs of photos	7 pairs of photos

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=21 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=25 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - HIF1alpha: Pathologist 3's Evaluation	0.05 percentage of cells that are positive Interval -0.13 to 0.22	-0.32 percentage of cells that are positive Interval -0.75 to 0.11

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

(e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=15 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=19 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 3's Evaluation	0.67 percentage of cells that are positive Interval -7.29 to 8.63	-7.37 percentage of cells that are positive Interval -20.6 to 5.86

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

(n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=11 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=18 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 3's Evaluation	5.91 percentage of cells that are positive Interval -15.85 to 27.67	-9.17 percentage of cells that are positive Interval -20.74 to 2.41

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=16 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=19 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - VEGF: Pathologist 3's Evaluation	4.81 percentage of cells that are positive Interval -11.92 to 21.55	-0.63 percentage of cells that are positive Interval -17.89 to 16.63

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=12 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=16 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - RelA: Pathologist 3's Evaluation	0.83 percentage of cells that are positive Interval -1.0 to 2.67	-1.25 percentage of cells that are positive Interval -6.26 to 3.76

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=10 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=17 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 3's Evaluation	1.00 percentage of cells that are positive Interval -13.09 to 15.09	1.18 percentage of cells that are positive Interval -10.59 to 12.94

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=15 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=20 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - Ki-67: Pathologist 3's Evaluation	0.73 percentage of cells that are positive Interval -1.48 to 2.94	0.50 percentage of cells that are positive Interval -0.39 to 1.39

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=23 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=25 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - HIF1alpha: Pathologist 4's Evaluation	-0.04 percentage of cells that are positive Interval -0.13 to 0.05	-0.04 percentage of cells that are positive Interval -0.12 to 0.04

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

(e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=22 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=25 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 4's Evaluation	4.23 percentage of cells that are positive Interval -6.72 to 15.17	-7.40 percentage of cells that are positive Interval -20.1 to 5.3

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

(n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=21 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=25 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 4's Evaluation	4.24 percentage of cells that are positive Interval -11.64 to 20.11	-3.52 percentage of cells that are positive Interval -9.45 to 2.41

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=23 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=25 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - VEGF: Pathologist 4's Evaluation	-1.83 percentage of cells that are positive Interval -8.08 to 4.43	-2.24 percentage of cells that are positive Interval -10.1 to 5.62

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=22 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=25 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - RelA: Pathologist 4's Evaluation	3.73 percentage of cells that are positive Interval -2.34 to 9.79	-3.44 percentage of cells that are positive Interval -10.98 to 4.1

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=20 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=23 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 4's Evaluation	2.05 percentage of cells that are positive Interval -3.48 to 7.58	-0.13 percentage of cells that are positive Interval -3.42 to 3.16

SECONDARY outcome

Timeframe: From baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=21 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=25 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Serum and Molecular Biomarkers - Ki-67: Pathologist 4's Evaluation	0.57 percentage of cells that are positive Interval -0.81 to 1.96	0.28 percentage of cells that are positive Interval -0.43 to 0.99

SECONDARY outcome

Timeframe: Baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=28 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=26 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Change in Cholesterol (mg/dL) From Baseline After Treatment	-27.25 mg/dL Interval -38.32 to -16.18	-3.77 mg/dL Interval -16.43 to 8.9

SECONDARY outcome

Timeframe: Baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=25 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=27 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Change in LDL (mg/dL) From Baseline After Treatment	-25.28 mg/dL Interval -35.6 to -14.96	-0.4 mg/dL Interval -12.54 to 11.74

SECONDARY outcome

Timeframe: Baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=24 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=27 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Change in HDL (mg/dL) From Baseline After Treatment	-1.42 mg/dL Interval -5.19 to 2.36	-2.63 mg/dL Interval -8.34 to 3.08

SECONDARY outcome

Timeframe: Baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=28 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=26 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Change in Triglycerides (mg/dL) From Baseline After Treatment	1.21 mg/dL Interval -8.67 to 11.1	1.65 mg/dL Interval -20.3 to 23.61

SECONDARY outcome

Timeframe: Baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=31 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=28 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Change in SGOT/AST (U/L) From Baseline After Treatment	3.42 U/L Interval -0.73 to 7.57	-0.75 U/L Interval -3.43 to 1.93

SECONDARY outcome

Timeframe: Baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=28 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=27 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Change in SGOT/ALT (U/L) From Baseline After Treatment	5.61 U/L Interval -0.5 to 11.72	2.93 U/L Interval -1.17 to 7.02

SECONDARY outcome

Timeframe: Baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=31 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=29 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Change in CPK (U/L) From Baseline After Treatment	20.94 U/L Interval -2.21 to 44.08	9.1 U/L Interval -18.76 to 36.96

SECONDARY outcome

Timeframe: Baseline up to 24 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=25 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=23 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
Change in C-reactive Protein (mg/dL) From Baseline After Treatment	-0.3 mg/dL Interval -0.96 to 0.37	-0.11 mg/dL Interval -0.26 to 0.03

SECONDARY outcome

Timeframe: Baseline up to 26 weeks

Population: One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm.

All participants will be evaluable for toxicity from the time of their informed consent. Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0.

Outcome measures

Measure	Two Matched Nevi Group - Lovastatin n=41 Participants Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group - Placebo n=39 Participants Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies
At Least 1 Study-related Adverse Event Reported During the Study Yes	14 participants	11 participants
At Least 1 Study-related Adverse Event Reported During the Study No	27 participants	28 participants

Adverse Events

Two Matched Nevi Group-Lovastatin

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Two Matched Nevi Group-Placebo

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

One Large Nevi Group-Lovastatin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

One Large Nevi Group-Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Two Matched Nevi Group-Lovastatin n=34 participants at risk Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group-Placebo n=32 participants at risk Patients receive placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	One Large Nevi Group-Lovastatin n=7 participants at risk Patients who have one large nevi received lovastatin PO QD for up to 6 months	One Large Nevi Group-Placebo n=7 participants at risk Patients who have one large nevi receive placebo PO QD for up to 6 months
Investigations ELEVATED CPK	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Investigations HYPERBILIRUBINEMIA	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.
Infections and infestations PNEUMONIA	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders ROTATOR CUFF SURGERY	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.

Other adverse events

Measure	Two Matched Nevi Group-Lovastatin n=34 participants at risk Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	Two Matched Nevi Group-Placebo n=32 participants at risk Patients receive placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies	One Large Nevi Group-Lovastatin n=7 participants at risk Patients who have one large nevi received lovastatin PO QD for up to 6 months	One Large Nevi Group-Placebo n=7 participants at risk Patients who have one large nevi receive placebo PO QD for up to 6 months
Respiratory, thoracic and mediastinal disorders SORE THROAT	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	6.2% 2/32 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders SPRAINED FINGER-PAIN	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders STOMACH ACHE	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders STOMACH DISCOMFORT	2.9% 1/34 • Number of events 3 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders STOMACH PAIN	11.8% 4/34 • Number of events 4 • The onset date of adverse event is between the randomization date and the date of off-study.	12.5% 4/32 • Number of events 5 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders STOMACH UPSET	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders STOMACH UPSET/GASTROENTERITIS	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Respiratory, thoracic and mediastinal disorders STREP THROAT	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	6.2% 2/32 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders 3 NEW MOLES	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders ACID REFLUX	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders ALOPECIA	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Investigations ALT SGPT	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders ARMS TINGLING AT NIGHT	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Investigations AST SGOT	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders ATYPICAL MOLE BIOPSY	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Infections and infestations BIOPSY SITE INFECTION	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Renal and urinary disorders BLADDER INFECTION	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders BLOATING	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Reproductive system and breast disorders BREAST TENDERNESS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Respiratory, thoracic and mediastinal disorders BRONCHITIS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
General disorders COLD	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	9.4% 3/32 • Number of events 3 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders COLD SORE OUTBREAK	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
General disorders COLD SYMPTOMS	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
General disorders COLD-FEVER	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders COLPOSCOPY-STOMACH DISCOMFORT	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Infections and infestations COMMON COLD	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders CONSTIPATION	8.8% 3/34 • Number of events 4 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	28.6% 2/7 • Number of events 3 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders CONSTIPATION( INTERMITTANT)	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Respiratory, thoracic and mediastinal disorders COUGH	5.9% 2/34 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	6.2% 2/32 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Investigations CPK	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders CRAMPS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Psychiatric disorders DECREASED LIBIDO	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders DIARRHEA	11.8% 4/34 • Number of events 6 • The onset date of adverse event is between the randomization date and the date of off-study.	21.9% 7/32 • Number of events 10 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders DIZZINESS	14.7% 5/34 • Number of events 7 • The onset date of adverse event is between the randomization date and the date of off-study.	12.5% 4/32 • Number of events 6 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders DIZZINESS - INTERMITTENT - 2-3 TIMES A WEEK	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders DRY FINGER TIPS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Investigations ELEVATED BILIRUBIN LEVEL	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Investigations ELEVATED CPK	8.8% 3/34 • Number of events 3 • The onset date of adverse event is between the randomization date and the date of off-study.	9.4% 3/32 • Number of events 4 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Investigations ELEVATED CREATINE KINASE	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Investigations ELEVATED LDH	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Investigations ELEVATED TOTAL CK	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Investigations ELEVATED TRIGLYCERIDES	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.
Renal and urinary disorders EXTRA URINE	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders FACELIFT	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
General disorders FATIGUE	14.7% 5/34 • Number of events 7 • The onset date of adverse event is between the randomization date and the date of off-study.	18.8% 6/32 • Number of events 8 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.
General disorders FEVER	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders FEVER SORE	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Reproductive system and breast disorders FIBROIDS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders FLATULENCE	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
General disorders FLU	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	6.2% 2/32 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
General disorders FLU-FEVER	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders GAS	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders HEADACHE	23.5% 8/34 • Number of events 12 • The onset date of adverse event is between the randomization date and the date of off-study.	28.1% 9/32 • Number of events 15 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 5 • The onset date of adverse event is between the randomization date and the date of off-study.	28.6% 2/7 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders HEARTBURN	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Cardiac disorders HIGH BLOOD PRESSURE	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Investigations HIGH CHOLESTEROL LEVEL	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders HIVES	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders INDIGESTION	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
General disorders INFLUENZA	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Psychiatric disorders INSOMNIA	11.8% 4/34 • Number of events 6 • The onset date of adverse event is between the randomization date and the date of off-study.	12.5% 4/32 • Number of events 4 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Psychiatric disorders INTERMITTENT INSOMNIA	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders INTERMITTENT NAUSEA	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders ITCHY AT BIOPSY SITE	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders ITCHY HAND	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders JOINT PAIN	8.8% 3/34 • Number of events 5 • The onset date of adverse event is between the randomization date and the date of off-study.	12.5% 4/32 • Number of events 5 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders JOINT/BONE PAIN	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Infections and infestations KIDNEY INFECTION	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Respiratory, thoracic and mediastinal disorders LARYNGITIS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders LEFT HIP PAIN	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders LEFT HIP SENSITIVITY	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders LIGHTHEADEDNESS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders LOOSE STOOLS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders LOWER BACK PAIN	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Reproductive system and breast disorders MENSTRUAL CRAMPS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders MIGRAINE	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders MOLE CHANGE, FATTER AND LIGHTER	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders MOLE ON NECK CHANGE IN APPEARANCE	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders MOLE REMOVAL	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders MOLES (2) BIOPSIED	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders MOTION SICKNESS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders MOUTH ULCERS	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders MUSCLE ACHE	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders MUSCLE CRAMPS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	6.2% 2/32 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders MUSCLE CRAMPS/PAIN	2.9% 1/34 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders MUSCLE PAIN	5.9% 2/34 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders MUSCLE PAIN - NECK, BACK, SHOULDER	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders MUSCLE PAIN AND ACHES;	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders MUSCLE TWITCHES IN THE UPPER LEFT ARM	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders NAUSEA	17.6% 6/34 • Number of events 7 • The onset date of adverse event is between the randomization date and the date of off-study.	31.2% 10/32 • Number of events 14 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders NECK PAIN-ARTHRITIC	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders NEW FOOT PAIN	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders NUMBNESS AND SHOOTING PAIN IN LOWER BACK AND LEGS	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders NUMBNESS AND TINGLING IN THE RIGHT ARM	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Reproductive system and breast disorders PAIN IN BREASTS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders PAIN LOWER BACK	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders PAIN-SHOULDER MUSCLE	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders PERIPHERAL NERVOUS SYSTEM ( PARESTHESIA) TINGLING SKIN- LEFT SIDE FACE.	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Respiratory, thoracic and mediastinal disorders PHARYNIGITIS	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders PNS LEFT HAND PARESTHESIA	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders PULLED BACK - LUMBAR SPINE INJURY	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders PULLED TENDON	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders RASH	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders RIB PAIN - INTERMITTENT	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders RIGHT HIP PAIN	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders RIGHT KNEE PAIN	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders RIGHT LEG WEAKNESS	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders ROOT CANAL	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders SCALY MOLE	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders SEBORRHEIC KERATOSIS	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders SHINGLES	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders SHOULDER PAIN	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Infections and infestations SINUS INFECTION	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	12.5% 4/32 • Number of events 4 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Respiratory, thoracic and mediastinal disorders SINUSITIS	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders SKIN CHANGES	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders SKIN RASH	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders SKIN REACTION TO BANDAID ADHESIVE	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders SKIN TAG CHANGE	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders SLIGHTLY ATYPICAL LENTIGO	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders SOFT STOOLS	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders SORE BACK	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders SORE CALF MUSCLES	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Skin and subcutaneous tissue disorders SUNBURN	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders SWOLLEN ANKLE	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders TEETH SENSITIVITY	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Endocrine disorders THYROID CANCER	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders TINGLING IN R PALM	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders TINGLING IN R THUMB & R INDEX	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders TINGLING IN THE FEET	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
General disorders TIRED	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders TOOTH PAIN	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Musculoskeletal and connective tissue disorders UNKNOWN CHANGE IN THE CERVICAL LYMPH NODE	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Nervous system disorders UNKNOWN PERIPHERAL NERVOUS SYSTEM	2.9% 1/34 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Infections and infestations UPPER RESPIRATORY INFECTION	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Infections and infestations URI	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	14.3% 1/7 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/34 • The onset date of adverse event is between the randomization date and the date of off-study.	3.1% 1/32 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Eye disorders VISUAL DISTURBANCES	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders VOMITING	5.9% 2/34 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	6.2% 2/32 • Number of events 2 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Gastrointestinal disorders WISDOM TEETH EXTRACTION - TOOTH PAIN	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.
Infections and infestations YEAST INFECTION	2.9% 1/34 • Number of events 1 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/32 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.	0.00% 0/7 • The onset date of adverse event is between the randomization date and the date of off-study.

Additional Information

Dr. Kenneth G. Linden

University of California, Irvine

Phone: 714-456-3719

Email: kglinden@uci.edu

Results disclosure agreements

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

Restriction type: LTE60