Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12-week Prospective, Double-blinded, Randomized, Multicenter Study of Low Dose and Medium Dose Botulinum Toxin Type A (Dysport® ) Injection for Migraine Prophylaxis.
Brief Summary: The purpose of this study is to determine whether 120 Unit, and 240 unit of botulinum toxin A are effective in the treatment of migraine without aura prophylaxis.


Options:
A: Inclusion Criteria:

* Frequent migraine (\>=15 headache days per month)
* \>=4 distinct headache episodes lasting \>=4 hours
* \>=50% of baseline headache days migraine/probable migraine days

Exclusion Criteria:

* Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype
* Any medical condition that puts the patient at increased risk with exposure to BOTOX
* Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache
* Use of prophylactic headache medication within 28 days prior to week -4
* Unremitting headache lasting continuously throughout the 4-week baseline period
* Known or suspected TMD
* Diagnosis of fibromyalgia
* Beck depression inventory score \>24 at week-4
* Psychiatric problems that may have interfered with study participation
B: Inclusion Criteria:

• The patient must give written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of the normal medical care of the patient.• Able to give written inform consent and have a copied one.• Male or female patient age 18 - 65.• Patients are fulfil the International Headache Society diagnostic criteria for migraine• Patients experience an average of 2 to 8 migraine attacks per month over the 3 months and if they recorded 2 to 8 migraine attacks during the screening period. • Patients with prophylactic treatment for migraine have been unchanged for 3 months. • Able to continuation anti - migraine drugs.• Female patient in good general health who is potentially fertile and sexually active must be instructed by the investigator to avoid pregnancy during the study by condom or other contraceptive measure and has negative urine pregnancy test. (if possible at each visit a control of the urine pregnancy test will be performed).• Patients have to judge reliable for medication compliance and recording the effects of medication, as well as clearly motivated to obtain benefit from treatment. • The normal physical and neurological examinations during the whole study period. • Normal result for haematology test • Liver transaminase inferior than 2 upper normal values of the laboratory.

Exclusion Criteria:

• Patients are fulfil the international Headache Society criteria diagnostic for pure migraine with aura.• The patient is pregnant or lactating.• The patient is a female at risk of pregnancy during the study, not taking adequate precautions against pregnancy.• The patient has a known hypersensitivity to any of the test materials or related compounds.• The patient is unable or unwilling to comply fully with the protocol.• The patient has received any unlicensed drug within the previous 6 months.• Treatment with investigational drug (s) within 6 months before the screening visit.• The patient has previously entered this study.• Patient with past history of predominant tension type headache, botulism, other neuromuscular disorder (e.g. myasthenia gravis, Lambert - Elton Syndrome)• Patient with significant medical / neurological / psychiatric disorders such as blood dyscrasia,thrombocytopenia, rheumatoid arthritis, congestive heart failure, coronary artery heart diseases, dementia, psychosis, major depression or other conditions which could influence the clinical trial. • History of drugs abuse (narcotic (s), cafergot, or others) or drug (botulinum toxin type A) allergy.• Treatment with BTX A within 6 month Treatment or any medical condition that may have put the participant at risk with exposure to BTX-A (neuromuscular disorders, aminoglycoside antibiotics, curare-like agents).• History of migrainous infarction, hemiplegic migraine.• Unable to fill patient diary at home during migraine attack.• Patient who plan to schedule elective surgery during the study.
C: Inclusion Criteria:

* Frequent migraine (\>=15 headache days per month)
* \>=4 distinct headache episodes lasting \>=4 hours
* \>=50% of baseline headache days migraine/probable migraine days

Exclusion Criteria:

* Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype
* Any medical condition that puts the patient at increased risk with exposure to BOTOX
* Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache
* Use of prophylactic headache medication within 28 days prior to week -4
* Unremitting headache lasting continuously throughout the 4-week baseline period
* Known or suspected Temporomandibular Disorders (TMD)
* Diagnosis of fibromyalgia
* Beck depression inventory score \>24 at week-4
* Psychiatric problems that may have interfered with study participation
D: Inclusion Criteria:

* History of migraine (with or without aura) for ≥ 12 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3) classification
* Migraine frequency: ≥ 4 and \< 15 migraine days per month on average across the 3 months prior to screening and during baseline
* Headache frequency: \< 15 headache days per month on average across the 3 months prior to screening and baseline
* Demonstrated at least 80% compliance with the eDiary.

Exclusion Criteria:

* Older than 50 years of age at migraine onset
* History of cluster headache or hemiplegic migraine headache
* Unable to differentiate migraine from other headache
* No therapeutic response with \> 2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial
* Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase
* Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study

Answer: B