Trial Outcomes & Findings for A Study to Evaluate Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period (NCT NCT03116698)

Last Updated: 2019-04-24

Results Overview

The proportion of subjects with complete clearance (absence of clinically visible or palpable AK lesions in the treatment area) of AK lesions at the End of Study Visit at 16 weeks (12 weeks treatment and 4 weeks treatment-free follow-up)

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

240 participants

Primary outcome timeframe

16 Weeks

Results posted on

2019-04-24

Participant Flow

Approximately 240 subjects were expected to be randomized, but 238 subjects were randomized and included in the ITT population and 183 subjects were included in the Per Protocol population.

Participant milestones

Participant milestones
Measure	DFD07 - 1.25% Once Daily Low dose DFD07 (1.25%) once daily: The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the study product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 0.5 g per day. In this group, the randomized active DFD-07 (celecoxib) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups.	DFD07 - 2.5% Once Daily High dose DFD07 (2.5%) once daily: The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the study product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 0.5 g per day. In this group, the randomized active DFD-07 (celecoxib) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups.	DFD07 - 2.5% Twice Daily High dose DFD07 (2.5%) twice daily: The active investigational product was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the study product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 1.0 g per day.	Vehicle Twice Daily Vehicle twice daily: The Vehicle product was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the Vehicle product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 1.0 g per day.
Overall Study STARTED	62	57	62	57
Overall Study COMPLETED	56	51	54	55
Overall Study NOT COMPLETED	6	6	8	2

Reasons for withdrawal

Reasons for withdrawal
Measure	DFD07 - 1.25% Once Daily Low dose DFD07 (1.25%) once daily: The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the study product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 0.5 g per day. In this group, the randomized active DFD-07 (celecoxib) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups.	DFD07 - 2.5% Once Daily High dose DFD07 (2.5%) once daily: The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the study product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 0.5 g per day. In this group, the randomized active DFD-07 (celecoxib) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups.	DFD07 - 2.5% Twice Daily High dose DFD07 (2.5%) twice daily: The active investigational product was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the study product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 1.0 g per day.	Vehicle Twice Daily Vehicle twice daily: The Vehicle product was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. The dose for the Vehicle product was a maximum of 0.5 g per application to the entire 5 cm x 5 cm area on the face and/or scalp for a maximum dose of 1.0 g per day.
Overall Study Adverse Event	1	1	1	0
Overall Study Withdrawal by Subject	1	4	5	2
Overall Study Lost to Follow-up	2	0	0	0
Overall Study Physician Decision	1	1	0	0
Overall Study Protocol Violation	1	0	0	0
Overall Study Death	0	0	2	0

Baseline Characteristics

A Study to Evaluate Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DFD07 Cream 1.25% Once Daily n=62 Participants DFD07 Cream (celecoxib 1.25%) once daily: The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. In this group, the randomized active DFD-07 (celecoxib 1.25%) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups.	DFD07 Cream 2.5% Once Daily n=57 Participants DFD07 Cream (celecoxib 2.5%) once daily: The active investigational product was applied once daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment. In this group, the randomized active DFD-07 (celecoxib 2.5%) Cream product was applied once daily in the evening, while the Vehicle for DFD-07 Cream was applied once daily in the morning to keep the blinding between groups.	DFD07 Cream 2.5% Twice Daily n=62 Participants DFD07 Cream (celecoxib 2.5%) twice daily: The active investigational product was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment.	Vehicle Cream Twice Daily n=57 Participants Vehicle Cream (celecoxib 0%) twice daily: The Vehicle Cream was applied twice daily for 12 weeks to cover the entire lesional area (5 cm x 5 cm) on the face and/or scalp identified by the Investigator for treatment.	Total n=238 Participants Total of all reporting groups
Age, Continuous	68.74 years STANDARD_DEVIATION 11.00 • n=93 Participants	65.71 years STANDARD_DEVIATION 11.54 • n=4 Participants	69.74 years STANDARD_DEVIATION 11.60 • n=27 Participants	66.66 years STANDARD_DEVIATION 11.21 • n=483 Participants	67.71 years STANDARD_DEVIATION 11.34 • n=36 Participants
Sex: Female, Male Female	25 Participants n=93 Participants	20 Participants n=4 Participants	23 Participants n=27 Participants	22 Participants n=483 Participants	90 Participants n=36 Participants
Sex: Female, Male Male	37 Participants n=93 Participants	37 Participants n=4 Participants	39 Participants n=27 Participants	35 Participants n=483 Participants	148 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=93 Participants	15 Participants n=4 Participants	18 Participants n=27 Participants	17 Participants n=483 Participants	66 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=93 Participants	42 Participants n=4 Participants	43 Participants n=27 Participants	38 Participants n=483 Participants	169 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	3 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	4 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants	11 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) White	58 Participants n=93 Participants	54 Participants n=4 Participants	61 Participants n=27 Participants	54 Participants n=483 Participants	227 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Region of Enrollment United States	62 participants n=93 Participants	57 participants n=4 Participants	62 participants n=27 Participants	57 participants n=483 Participants	238 participants n=36 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Population: Intent To Treat (ITT) population defined as all subjects who were randomized and dispensed study medication.

Outcome measures

Outcome measures
Measure	DFD07 Cream (Celecoxib 1.25%) Once Daily n=62 Participants DFD07 Cream (Celecoxib 1.25%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.	DFD07 Cream (Celecoxib 2.5%) Once Daily n=57 Participants DFD07 Cream (Celecoxib 2.5%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.	DFD07 Cream (Celecoxib 2.5%) Twice Daily n=62 Participants DFD07 Cream (Celecoxib 2.5%) Twice daily for 12 weeks followed by 4 weeks treatment-free period	Vehicle Cream (Celecoxib 0%) Twice Daily n=57 Participants Vehicle Cream (Celecoxib 0%) Twice daily for 12 weeks followed by 4 weeks treatment-free period
Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks	6 Participants	9 Participants	10 Participants	7 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: ITT Population

Proportion of subjects with partial clearance of AK lesions at week 16 (12 weeks treatment and 4 weeks treatment free follow up period)

Outcome measures

Outcome measures
Measure	DFD07 Cream (Celecoxib 1.25%) Once Daily n=62 Participants DFD07 Cream (Celecoxib 1.25%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.	DFD07 Cream (Celecoxib 2.5%) Once Daily n=57 Participants DFD07 Cream (Celecoxib 2.5%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.	DFD07 Cream (Celecoxib 2.5%) Twice Daily n=62 Participants DFD07 Cream (Celecoxib 2.5%) Twice daily for 12 weeks followed by 4 weeks treatment-free period	Vehicle Cream (Celecoxib 0%) Twice Daily n=57 Participants Vehicle Cream (Celecoxib 0%) Twice daily for 12 weeks followed by 4 weeks treatment-free period
Proportion of Subjects With Partial Clearance at Week 16	14 Participants	19 Participants	17 Participants	18 Participants

Adverse Events

DFD07 Cream (Celecoxib 1.25%) Once Daily

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

DFD07 Cream (Celecoxib 2.5%) Once Daily

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

DFD07 Cream (Celecoxib 2.5%) Twice Daily

Serious events: 2 serious events

Other events: 21 other events

Deaths: 2 deaths

Vehicle Cream (Celecoxib 0%) Twice Daily

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DFD07 Cream (Celecoxib 1.25%) Once Daily n=62 participants at risk DFD07 Cream (Celecoxib 1.25%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.	DFD07 Cream (Celecoxib 2.5%) Once Daily n=57 participants at risk DFD07 Cream (Celecoxib 2.5%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.	DFD07 Cream (Celecoxib 2.5%) Twice Daily n=62 participants at risk DFD07 Cream (Celecoxib 2.5%) Twice daily for 12 weeks followed by 4 weeks treatment-free period	Vehicle Cream (Celecoxib 0%) Twice Daily n=57 participants at risk Vehicle Cream (Celecoxib 0%) Twice daily for 12 weeks followed by 4 weeks treatment-free period
Cardiac disorders Atrial Fibrillation	0.00% 0/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.6% 1/62 • Number of events 1 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease (COPD)	0.00% 0/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.6% 1/62 • Number of events 1 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)

Other adverse events

Additional Information

Dr. Srinivas Sidgiddi

Dr. Reddy's Laboratories Inc.

Phone: 6093759910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	DFD07 Cream (Celecoxib 1.25%) Once Daily n=62 participants at risk DFD07 Cream (Celecoxib 1.25%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.	DFD07 Cream (Celecoxib 2.5%) Once Daily n=57 participants at risk DFD07 Cream (Celecoxib 2.5%) Once daily for 12 weeks followed by 4 weeks treatment-free period. In this group active treatment was applied once daily in the evening and Vehicle treatment was applied once daily in the morning for 12 weeks to maintain study blind.	DFD07 Cream (Celecoxib 2.5%) Twice Daily n=62 participants at risk DFD07 Cream (Celecoxib 2.5%) Twice daily for 12 weeks followed by 4 weeks treatment-free period	Vehicle Cream (Celecoxib 0%) Twice Daily n=57 participants at risk Vehicle Cream (Celecoxib 0%) Twice daily for 12 weeks followed by 4 weeks treatment-free period
Infections and infestations Infections	11.3% 7/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	3.5% 2/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	8.1% 5/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	3.5% 2/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Cardiac disorders Cardiac Disorders	0.00% 0/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.6% 1/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Gastrointestinal disorders Gastrointestinal Disorders	3.2% 2/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	3.2% 2/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	3.5% 2/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
General disorders Application site events	1.6% 1/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.6% 1/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Immune system disorders Immune disorders	1.6% 1/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	3.5% 2/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Injury, poisoning and procedural complications Injuries	1.6% 1/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	3.2% 2/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Investigations Laboratory test abnormalities	1.6% 1/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Metabolism and nutrition disorders Metabolic disorders	0.00% 0/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.6% 1/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Musculoskeletal and connective tissue disorders Musculoskeletal disorders	0.00% 0/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	3.2% 2/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms	1.6% 1/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	3.2% 2/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Nervous system disorders Nervous system disorders	3.2% 2/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	3.5% 2/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	4.8% 3/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Respiratory, thoracic and mediastinal disorders Respiratory events	0.00% 0/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.6% 1/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Skin and subcutaneous tissue disorders Skin disorders	4.8% 3/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	6.5% 4/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	3.5% 2/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Surgical and medical procedures Procedures	3.2% 2/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	1.8% 1/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)
Vascular disorders Vascular disorders	0.00% 0/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	3.2% 2/62 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)	0.00% 0/57 • All Adverse events that occurred during the treatment period from the Baseline visit (Day 1) until the end of study (Week 16)