Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised, Controlled, Multidose, Multicentre, Adaptive Phase II/III Study in Infants With Proliferating Infantile Hemangiomas (IHs) Requiring Systemic Therapy to Compare 4 Regimens of Propranolol (1 or 3 mg/kg/Day for 3 or 6 Months) to Placebo (Double Blind).
Brief Summary: There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.


Options:
A: Inclusion Criteria:

* Proliferating IH (target hemangioma) requiring systemic therapy anywhere on the body except on the diaper area with largest diameter of at least 1.5 cm

Exclusion Criteria:

- The patient presents with one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycaemia (\< 40 mg/dl or at risk); untreated phaeochromocytoma; hypotension (\< 50/30 mmHg); second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia (\< 80 bpm); severe peripheral arterial circulatory disturbances; Raynaud's phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal's angina; documented PHACES syndrome with central nervous system involvement

* The patient has previously been treated for IH, including any surgical and/or medical procedures (e.g. laser therapy)
* The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers
* One or more of the following types of IH are present:

  * Life-threatening IH
  * Function-threatening IH (e.g. those causing impairment of vision, respiratory compromise caused by airway lesions, etc.)
  * Ulcerated IH (whatever the localisation) with pain and lack of response to simple wound care measures
* The patient was born prematurely and has not yet reached his/her term equivalent age (e.g. an infant born 2 months prematurely cannot be included before the age of 2 months)
* LVEF (left ventricular systolic function) ≤40% and/or cardiomyopathy and/or hereditary arrhythmia disorder
B: Inclusion Criteria:

* infants with symptomatic hemangiomas

Exclusion Criteria:

* asthma
* diabetes
* hypertension
* hypotension
* hypoglycemia
* liver failure
* previous treatment for hemangiomas
C: Inclusion Criteria:

* Healthy infants aged 2-12 months.
* Superficial or mixed hemangiomas in proliferative phase (growing in size in the last 1-2 months).
* Hemangiomas must be less than 10X10 cm and must not be ulcerated.

Exclusion Criteria:

* Preterm infant (less than 36 weeks of gestation).
* Ulceration of hemangioma prior to treatment.
* Immunosuppression.
* Hemangioma located on the eyelid or perianal region.
* Prior treatment of the hemangioma.
* Concomitant diseases.
* Presence of multiple hemangiomas and/or hemangiomas that would require systemic drug treatment.
* Potential difficulties with follow-up (patient from another town,difficult access to the hospital , etc.).
* History of allergy to any of the components of the drug preparation.
* Hemangiomas more than 10X 10 cm or ulcerated before the start of the treatment.
D: Inclusion Criteria:

* preterm infants \<=34 weeks GA with hemangioma

Exclusion Criteria:

* no hemangioma

Answer: A