Please select the eligibility criteria that correspond to the clinical trial below.
Title: LEVP2005-1/Part B: A Double-blind, Placebo-Controlled, Clinical Study to Investigate the Efficacy and Safety of Purified C1 Esterase Inhibitor (Human) as Prophylactic Treatment to Prevent HAE Attacks
Brief Summary: The study objective was to determine the safety and efficacy of C1INH-nf for the prevention of acute HAE attacks.


Options:
A: Key Inclusion Criteria:

1. A clinical diagnosis of HAE type I or II
2. Documented HAE attacks within a defined calendar period; in the absence of documented HAE attacks, subjects will be required to enter a run-in period to document attacks
3. Access to acute attack medications
4. Sexually active women of child-bearing potential and sexually active men must utilize highly effective contraception

Key Exclusion Criteria:

1. Women who are pregnant or breast-feeding
2. Any clinical condition or medical history that would interfere with the subject's safety or ability to participate in the study
3. Use of C1INH or tranexamic acid for prophylaxis of HAE attacks
4. Current participation in any other investigational drug study or within the last 30 days
5. History of or current alcohol or drug abuse
6. Infection with hepatitis B, hepatitis C or HIV
B: Inclusion Criteria:

1. Diagnosis of at least 1 of the following:

   * Hereditary angioedema (HAE) type I or II
   * HAE with normal C1 inhibitor
   * ACE-I-induced angioedema
   * Non-histaminergic idiopathic angioedema
   * Acquired angioedema.
2. Signed and dated written informed consent from the participant or, for participants aged less than(\<)18 years (or as per local regulation, such as \<16 years in the United Kingdom \[UK\]), parent and/or participants legally authorized representative (LAR), and assent of the minor where applicable.
3. At sites only participating in the drug registry, participants must have taken at least 1 dose of Firazyr (Icatibant) or Cinryze (C1 inhibitor \[human\]).
4. Enrolled participants in Germany taking Firazyr (Icatibant) or Cinryze (C1 inhibitor \[human\]) will only use the respective product in accordance with the product label.

Exclusion Criteria:

1. Participants enrolled in clinical trials where the product is blinded or where the product under investigation is for the treatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema.
2. Participants enrolled in another Shire-sponsored registry involving products for the treatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema. An exception applies to participants enrolled in the Shire lanadelumab ENABLE study.
C: Inclusion Criteria:

* Documented HAE
* Normal C1q level
* Relatively frequent angioedema attacks (at least 2 per month on average)

Exclusion Criteria:

* Low C1q level
* B-cell malignancy
* Presence of anti-C1INH autoantibody
* History of allergic reaction to C1INH or other blood products
* Narcotic addiction
* Current participation in any other investigational drug study or within the past 30 days
* Participation in a C1 esterase inhibitor trial, or received blood or a blood product in the past 90 days
* Pregnancy or lactation
* Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study
D: Inclusion Criteria:

* Documented HAE
* Normal C1q level

Exclusion Criteria:

* Low C1q level
* B-cell malignancy
* Presence of anti-C1INH autoantibody
* History of allergic reaction to C1INH or other blood products
* Narcotic addiction
* Current participation in any other investigational drug study or within the past 30 days
* Participation in a C1 esterase inhibitor trial, or received blood or a blood product in the past 90 days
* Pregnancy or lactation
* Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study

Answer: C