Please select the eligibility criteria that correspond to the clinical trial below.
Title: Oral Cleft Prevention Program
Brief Summary: The purpose of this study is to asses if taking 4 mg of folic acid per day at preconception and during the first three months of pregnancy decreases the risk of having a child with cleft lip and palate compared to 0.4 mg folic acid for women who have an oral cleft or have had previously child with an oral cleft.


Options:
A: Inclusion Criteria:

* Parasitemia with a parasite density of ≥ 500 parasites/microliter
* Gestational age \> 16 weeks and \< 35 weeks
* Willingness to provide blood samples and participate in HIV counseling and testing
* Available for follow up for the entire study period
* Hemoglobin \> 7 g/dl
* Age 15-45 years

Exclusion Criteria:

* Use of folate in the last 4 weeks
* Gestational age \<16 weeks or \>35 weeks
* History of an allergy to sulfonamides or other unknown drugs
* Intake of sulfa-containing drugs or 4-aminoquinolones in the previous month
* A urine test positive for sulfa-compounds
* Sickle cell disease
* Concomitant diseases needing treatment with co-trimoxazole or other sulfa-containing drug
* Hemoglobin \< 7 g/dl
* Severe malaria or any other serious medical condition requiring hospitalization and/or additional treatment. Clinical danger signs of severe malaria include prostration, impaired consciousness, respiratory distress, multiple convulsions, circulatory collapse, pulmonary oedema, abnormal bleeding, jaundice, and hemoglobinuria. Laboratory signs of severe malaria include severe anemia (hemoglobin \< 7 g/dl), hypoglycemia, acidosis, hyperlactataemia, hyperparasitaemia (a parasitemia \> 100,000 parasites/µl), and renal impairment
B: Inclusion Criteria:

* Women with cleft lip with/out palate (CLP), 16 to 45 years of age registered at the study clinics in Brazil or Women (16 to 45 years of age) with at least one natural child of any age with CLP registered at the study clinics.
* Women must reside in the catchment area of the study, which includes the states where the study clinics are located and surrounding states.

Exclusion Criteria:

* Consanguineous couples (up to third degree, i.e. first cousins or closer).
* Pregnany at the time of recruitment. Women will be recontacted later at an appropriate time for participation in the study.
* Couples either one of which have been sterilized.
* Taking any form of seizure medication.
* Planning to move outside of the study catchment area within the next year.
* B12 deficiency (\<174 pg/mL or 129.15 pmol/L).
* Being allergic to folic acid.
C: Inclusion Criteria:

* Married women of reproductive age identified as a new pregnancy using a urine test

Exclusion Criteria:

* Menopausal or sterilized woman or currently already pregnant or breastfeeding an infant \<9 months of age
D: Inclusion Criteria:

1. Girls aged \> =15 years and \<= 29 years
2. Have not missed a menstrual period during recruitment (no amenorrhea)
3. Has not been pregnant or given birth within the last 6 months
4. Intend to stay in the study area for at least 6 months after enrollment
5. Have provided written informed consent

Exclusion Criteria:

1. Amenorrhea or confirmed pregnancy at screening or enrollment.
2. Has given birth within 6 months
3. Already taking long-term vitamin supplementation.
4. Any severe illness requiring hospitalization at screening or enrollment (women who have been deemed to have recovered will be eligible once they return home).

Answer: B