Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-1)
Brief Summary: This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.


Options:
A: Inclusion Criteria:

1. Provision of written informed consent prior to any study related procedures.
2. Male or female between 18 and 65 years of age, inclusive.
3. Had moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at baseline (Day 1), as assessed by the ILA using a validated 4-point photographic scale.
4. Had moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at baseline (Day 1), as assessed by the SSA using a validated 4-point categorical scale.
5. Were dissatisfied or very dissatisfied (Grade 2 or 3) with their glabellar lines at baseline (Day 1), as assessed by the subject's level of satisfaction.
6. Had a negative pregnancy test (for females of childbearing potential only). Nonchildbearing potential was defined as post menopausal for at least 1 year, surgical sterilisation at least 3 months before entering the study, or hysterectomy.
7. Had both the time and the ability to complete the study and comply with study instructions.

Exclusion Criteria:

1. Previous treatment with any serotype of botulinum toxin (BTX).
2. Any prior treatment with permanent fillers in the upper face including the glabellar lines area.
3. Any prior treatment with long lasting dermal fillers in the upper face including the glabellar lines area within the past 3 years and/or skin abrasions/resurfacing (whatever the interventional technic used) within the past 5 years, or photorejuvenation or skin/vascular laser intervention within the past 12 months.
4. Any planned facial cosmetic surgery during the study.
5. A history of eyelid blepharoplasty or brow lift within the past 5 years.
6. An inability to substantially reduce glabellar lines by physically spreading them apart or lack of capacity to frown.
7. An active infection or other skin problems in the upper face including the glabellar lines area (e.g. acute acne lesions or ulcers).
8. Use of concomitant therapy which, in the Investigator's opinion, would have interfered with the evaluation of the safety or efficacy of the study treatment, including medications affecting bleeding disorders (antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases).
9. Pregnant women, nursing mothers, or women who were planning a pregnancy during the study, or believed they may be pregnant at the start of the study. Throughout the course of the study, women of childbearing potential had to use a reliable form of contraception (e.g. oral contraceptives for more than 12 consecutive weeks, or spermicide and condoms).
10. A history of drug or alcohol abuse.
11. Treatment with an experimental drug or use of any experimental device within 30 days prior to the start of the study and during the conduct of the study.
12. Known allergy or hypersensitivity to any serotype of BTX or any component of BTX-A-HAC NG.
13. Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the subject's participation in the study.
14. Use of medications that affect neuromuscular transmission, such as curare like nondepolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within the past 30 days.
15. A history of facial nerve palsy.
16. Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
17. The presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function), laboratory finding or circumstance that, in the judgement of the Investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
B: Inclusion Criteria:

* Provide written informed consent including authorization to release health information
* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale
* Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Active skin disease, infections or inflammation at the injection sites
* Plan to receive botulinum toxin type A anywhere in the face through the duration of the study
* History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article
* Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial
C: Inclusion Criteria:

* Provide written informed consent including authorization to release health information
* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
* Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale
* Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Active skin disease, infections or inflammation at the injection sites
* Plan to receive botulinum toxin type A anywhere in the face through the duration of the study
* History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article
* Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial
D: Inclusion Criteria:

* Moderate or severe glabellar frown lines
* Female or male, 30 to 65 years of age in good general health
* Women of childbearing potential must agree to use an effective method of birth control during the course of the study
* Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
* Muscle weakness or paralysis, particularly in the treatment area
* Active skin disease or infections or irritation at the treatment area
* Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart
* Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body

Answer: B