Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Randomised, Double-blind and Open Label Phase, Active and Placebo Controlled Study Comparing the Short-term Efficacy of Two Formulations of Clostridium Botulinum Type A Toxin (Dysport and Dysport NG) to Placebo, and Assessing the Short and Long Term Efficacy and Safety of Dysport NG Following Repeated Treatments of Subjects With Cervical Dystonia
Brief Summary: The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.


Options:
A: Inclusion Criteria:

* Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal
* Returned to pre-treatment status as judged by the Investigator

Exclusion Criteria:

* Pure anterocollis or pure retrocollis
* Known antibodies to botulinum toxin type A
* Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study
* Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment
B: Inclusion Criteria:

* A diagnosis of idiopathic CD as determined by the enrolling investigator
* If previously treated with a neurotoxin for CD, at least a 12-week interval must have elapsed between the last injection of Botulinum toxin A (BoNT-A) or Botulinum toxin B (BoNT-B) and the first dose of Dysport injected in this study
* Patient is able to comply with the protocol (e.g., can visit the clinic as required and can complete questionnaires/telephone interviews)
* Provision of written informed consent prior to enrollment

Exclusion Criteria:

* Contraindications to treatment with any BoNT-A or BoNT-B preparations
* Based on Investigator opinion, patients in whom previous BoNT-A or BoNT-B therapy has failed to produce a clinical response or produced an intolerable adverse reaction
* Anticipated concomitant treatment with BoNT for other than cervical dystonia
* Secondary cervical dystonia
C: Inclusion Criteria:

* Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
* TWSTRS total score≥ 20; TWSTRS-severity subscale score\> 10;

Exclusion Criteria:

* In apparent remission from Cervical Dystonia
* Diagnosis of pure retrocollis or pure anterocollis
* For non-naïve subjects, previous poor response to either of the last two Botox treatments
* Known requirement of \<100U or \>200U of Botox injected into the neck muscles
D: Inclusion Criteria:

* Dystonia with at least 18 months duration since onset.
* Previously untreated with Botulinum toxin-A (BTX-A) or -B or a minimum of 14 weeks since the last injection.
* TWSTRS score at baseline of: Total score ≥ 30, Severity Sub-Scale score ≥ 15, Disability Sub-Scale score ≥ 3, Pain Sub-Scale score ≥ 2.

Exclusion Criteria:

* Known hypersensitivity to Botulinum toxin (BTX) or related compounds or any component in the study drug formulation (including cow milk protein).
* Pure anterocollis or pure retrocollis.
* In apparent remission from Cervical Dystonia.
* Known clinically significant underlying swallowing or respiratory abnormality which might be exacerbated by BTX treatment.
* Previous poor response to BTX treatment or known presence of BTX neutralising antibodies.
* Previous phenol or alcohol injections into the neck muscles.
* Previous myotomy or denervation surgery involving the neck or shoulder region.

Answer: D