Trial Outcomes & Findings for Phase 3 Papulopustular Rosacea Study (NCT NCT01494467)

Last Updated: 2021-02-18

Results Overview

Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale: Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

688 participants

Primary outcome timeframe

Week 12

Results posted on

2021-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	CD5024 1% Cream Part A \& B: CD5024 1% Cream, once daily application	CD5024 Vehicle Cream/Azelaic Acid 15% Gel Part A: CD5024 Vehicle Cream, once daily application Part B: Azelaic acid 15% Gel, twice daily application
Part A Vehicle Control (12 Weeks) STARTED	459	229
Part A Vehicle Control (12 Weeks) COMPLETED	429	208
Part A Vehicle Control (12 Weeks) NOT COMPLETED	30	21
Part B Long Term Active Control 40 Weeks STARTED	428	208
Part B Long Term Active Control 40 Weeks COMPLETED	353	159
Part B Long Term Active Control 40 Weeks NOT COMPLETED	75	49
Part C Safety Follow up (4 Weeks) STARTED	353	159
Part C Safety Follow up (4 Weeks) COMPLETED	353	159
Part C Safety Follow up (4 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CD5024 1% Cream Part A \& B: CD5024 1% Cream, once daily application	CD5024 Vehicle Cream/Azelaic Acid 15% Gel Part A: CD5024 Vehicle Cream, once daily application Part B: Azelaic acid 15% Gel, twice daily application
Part A Vehicle Control (12 Weeks) Pregnancy	1	0
Part A Vehicle Control (12 Weeks) Adverse Event	6	4
Part A Vehicle Control (12 Weeks) Withdrawal by Subject	9	8
Part A Vehicle Control (12 Weeks) Protocol Violation	4	0
Part A Vehicle Control (12 Weeks) Lost to Follow-up	8	8
Part A Vehicle Control (12 Weeks) Other	1	1
Part A Vehicle Control (12 Weeks) Lack of Efficacy	1	0
Part B Long Term Active Control 40 Weeks Pregnancy	2	0
Part B Long Term Active Control 40 Weeks Lack of Efficacy	1	3
Part B Long Term Active Control 40 Weeks Adverse Event	3	5
Part B Long Term Active Control 40 Weeks Withdrawal by Subject	32	24
Part B Long Term Active Control 40 Weeks Protocol Violation	3	5
Part B Long Term Active Control 40 Weeks Lost to Follow-up	26	10
Part B Long Term Active Control 40 Weeks Other (noted in eCRF)	8	2

Baseline Characteristics

Phase 3 Papulopustular Rosacea Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CD5024 1% Cream n=459 Participants Part A: CD5024 1% Cream, once daily application for 12 weeks Part B: CD5024 1% Cream, once daily application for 40 weeks	CD5024 Vehicle Cream/Azelaic Acid 15% Gel n=229 Participants Part A: CD5024 Vehicle Cream, once daily application for 12 weeks Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks	Total n=688 Participants Total of all reporting groups
Race (NIH/OMB) White	438 Participants n=5 Participants	218 Participants n=7 Participants	656 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Skin Photo Type I	48 Participants n=5 Participants	22 Participants n=7 Participants	70 Participants n=5 Participants
Skin Photo Type II	211 Participants n=5 Participants	96 Participants n=7 Participants	307 Participants n=5 Participants
Skin Photo Type III	139 Participants n=5 Participants	71 Participants n=7 Participants	210 Participants n=5 Participants
Age, Continuous	50.5 Year STANDARD_DEVIATION 12.35 • n=5 Participants	49.5 Year STANDARD_DEVIATION 12.16 • n=7 Participants	50.2 Year STANDARD_DEVIATION 12.29 • n=5 Participants
Sex: Female, Male Female	314 Participants n=5 Participants	145 Participants n=7 Participants	459 Participants n=5 Participants
Sex: Female, Male Male	145 Participants n=5 Participants	84 Participants n=7 Participants	229 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants n=5 Participants	31 Participants n=7 Participants	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	403 Participants n=5 Participants	198 Participants n=7 Participants	601 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Skin Photo Type IV	50 Participants n=5 Participants	31 Participants n=7 Participants	81 Participants n=5 Participants
Skin Photo Type V	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Skin Photo Type VI	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: LOCF, ITT

Outcome measures

Outcome measures
Measure	CD5024 1% Cream n=459 Participants CD5024 1% Cream, once daily application for 12 weeks	CD5024 Vehicle Cream n=229 Participants CD5024 Vehicle Cream, once daily application for 12 weeks
Success Rate	40.1 Percentage of participants	18.8 Percentage of participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: LOCF, ITT

Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).

Outcome measures

Outcome measures
Measure	CD5024 1% Cream n=459 Participants CD5024 1% Cream, once daily application for 12 weeks	CD5024 Vehicle Cream n=229 Participants CD5024 Vehicle Cream, once daily application for 12 weeks
Absolute Change in Inflammatory Lesion Count	-22.2 Lesion count change Standard Deviation 14.87	-13.4 Lesion count change Standard Deviation 14.48

SECONDARY outcome

Timeframe: Baseline to Week 12

Outcome measures

Outcome measures
Measure	CD5024 1% Cream n=459 Participants CD5024 1% Cream, once daily application for 12 weeks	CD5024 Vehicle Cream n=229 Participants CD5024 Vehicle Cream, once daily application for 12 weeks
Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)	-65.7 Percentage of change in lesion counts Standard Deviation 33.18	-43.4 Percentage of change in lesion counts Standard Deviation 38.42

Adverse Events

CD5024 1% Cream - Part A

Serious events: 7 serious events

Other events: 33 other events

Deaths: 0 deaths

CD5024 Vehicle Cream - Part A

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

CD5024 1% Cream - Part B

Serious events: 13 serious events

Other events: 102 other events

Deaths: 0 deaths

Azelaic Acid 15% Gel - Part B

Serious events: 4 serious events

Other events: 47 other events

Deaths: 0 deaths

CD5024 1% Cream - Part C

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

CD5024 1% Cream - Overall

Serious events: 18 serious events

Other events: 125 other events

Deaths: 0 deaths

CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall

Serious events: 9 serious events

Other events: 64 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CD5024 1% Cream - Part A n=458 participants at risk Part A: CD5024 1% Cream, once daily application for 12 weeks	CD5024 Vehicle Cream - Part A n=230 participants at risk Part A: CD5024 Vehicle Cream, once daily application for 12 weeks	CD5024 1% Cream - Part B n=428 participants at risk Part B CD5024 1% Cream, once daily application for 40 weeks	Azelaic Acid 15% Gel - Part B n=208 participants at risk Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks	CD5024 1% Cream - Part C n=353 participants at risk Part C: 4 week safety follow up. No drug applications	CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C n=159 participants at risk Part C: 4 week safety follow up. No drug applications	CD5024 1% Cream - Overall n=460 participants at risk Overall number of subjects with adverse events for the entire duration of study	CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall n=231 participants at risk Overall number of subjects with adverse events for the entire duration of study
Cardiac disorders Atrial fibrillation	0.22% 1/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 2/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Cardiac disorders Angina pectoris	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.48% 1/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Cardiac disorders Myocardial ischaemia	0.22% 1/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Cardiac disorders Sick sinus syndrome	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Cardiac disorders Cardiac failure	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Cardiac disorders Aortic valve stenosis	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.48% 1/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.22% 1/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Psychiatric disorders Depression	0.44% 2/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 2/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Psychiatric disorders Major depression	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Hepatobiliary disorders Cholecystis chronic	0.22% 1/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Hepatobiliary disorders Cholecystitis	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Nervous system disorders Multiple sclerosis	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Nervous system disorders Cerebrovascular accident	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Nervous system disorders Headache	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.48% 1/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Nervous system disorders Transient ischaemic attack	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.48% 1/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Ear and labyrinth disorders Vertigo	0.22% 1/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Gastrointestinal disorders Colonic obstruction	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Immune system disorders Anaphylactic reaction	0.22% 1/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Infections and infestations Pneumonia	0.22% 1/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Infections and infestations Diverticulitis	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.48% 1/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.48% 1/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Metabolism and nutrition disorders Dehydration	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.23% 1/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.22% 1/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Reproductive system and breast disorders Menorrhagia	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
General disorders Chest discomfort	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.48% 1/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Renal and urinary disorders Nephrolithiasis	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.63% 1/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Vascular disorders Hypertension	0.00% 0/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.43% 1/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.48% 1/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.87% 2/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).

Other adverse events

Other adverse events
Measure	CD5024 1% Cream - Part A n=458 participants at risk Part A: CD5024 1% Cream, once daily application for 12 weeks	CD5024 Vehicle Cream - Part A n=230 participants at risk Part A: CD5024 Vehicle Cream, once daily application for 12 weeks	CD5024 1% Cream - Part B n=428 participants at risk Part B CD5024 1% Cream, once daily application for 40 weeks	Azelaic Acid 15% Gel - Part B n=208 participants at risk Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks	CD5024 1% Cream - Part C n=353 participants at risk Part C: 4 week safety follow up. No drug applications	CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C n=159 participants at risk Part C: 4 week safety follow up. No drug applications	CD5024 1% Cream - Overall n=460 participants at risk Overall number of subjects with adverse events for the entire duration of study	CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall n=231 participants at risk Overall number of subjects with adverse events for the entire duration of study
Infections and infestations Nasopharyngitis	2.2% 10/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	2.6% 6/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	10.0% 43/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	8.7% 18/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.28% 1/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.63% 1/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	11.3% 52/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	10.0% 23/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Infections and infestations Upper respiratory tract infection	2.6% 12/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	3.5% 8/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	9.3% 40/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	8.2% 17/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.28% 1/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	1.3% 2/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	10.4% 48/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	10.0% 23/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Infections and infestations Sinusitis	2.0% 9/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	2.6% 6/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	4.7% 20/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	3.4% 7/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.57% 2/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	6.5% 30/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	5.6% 13/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
Skin and subcutaneous tissue disorders Skin irritation	0.66% 3/458 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	3.0% 7/230 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.93% 4/428 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	3.8% 8/208 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/353 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	0.00% 0/159 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	1.3% 6/460 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).	6.5% 15/231 • Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).

Additional Information

Clinical Science Director

Galderma R&D, LLC

Phone: 609-409-7701

Results disclosure agreements

Principal investigator is a sponsor employee At least sixty (60) days prior to submission for publication, presentation or use, the Institution and the Investigator shall submit in writing to the Contract Research Organization and Sponsor for review and comment any proposed oral or written publication, which period may be extended for an additional thirty (30) days if requested in writing by Contract Research Organization and Sponsor.
Publication restrictions are in place

Restriction type: OTHER