Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Study Of Impact Of Intermittent Preventive Treatment In Children With Amodiaquine Plus Artesunate Versus Sulphadoxine-Pyrimethamine On Hemoglobin Levels And Malaria Morbidity In Hohoe District Of Ghana
Brief Summary: Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.


Options:
A: Inclusion Criteria:

* Permanent residence in the study area with no intention of leaving during the surveillance period.
* Obtention of informed consent.

Exclusion Criteria:

* Temporary residence in the study area.
* Absence of informed consent.
* Presence of a severe, chronic illness such as severe malnutrition (Kwashiorkor or marasmus) or AIDS, likely to interfere with evaluation of the trial results.
* A history of a previous, significant adverse reaction to either of the study drugs.
B: Inclusion Criteria:

* Children aged 6 months to 5 years admitted to Mulago hospital during the study period who satisfy the World Health Organization (WHO) case definition of cerebral malaria (Unarousable coma lasting more than 30 minutes after a seizure, with peripheral asexual P.falciparum parasitaemia and absence of other causes of coma) and whose caretakers give informed consent.

Exclusion Criteria:

* Patients with diarrhea (more than 4 motions/24 hours)
* Any recent anal pathology (such as rectal bleeding, rectal prolapse)
* Documented quinine treatment in previous 48 hours.
C: Inclusion Criteria:

All children aged 12 months to 6 years in the 13 study villages will be enrolled in the study and followed up for the duration of the study. The inclusion criteria for randomization will be:

1. Children aged 12 months to 6 years; and
2. History of fever in the preceding 48 hours or a measured temperature \> 37.5oC plus asexual forms of P. falciparum in the peripheral blood film of 500/μl or above; and
3. Hb \<110g/l and \>69g/l (Our choice of the upper limit of moderate anaemia (70 - 79g/l) is to enable us assess the response to our interventions of severer forms of anaemia while at the same time reducing the risk of adverse events which might occur with lower levels of Hb).

Exclusion Criteria:

1. Refusal of parent or guardian to give consent to the child's participation in the study
2. Inability of the subjects to take oral medications
3. Presence of features of severe malaria as defined by WHO50, with the exception of anaemia and parasite density
4. Children who have urgent need for blood transfusion as indicated by the presence of tachypnoea, tachycardia \& gallop rhythm, tender hepatomegaly
5. Children with known haemoglobinopathy
6. Children with a weight for height Z score below -3SD of WHO/NCHS standard
7. Enrolment in another research project
D: Inclusion Criteria:

* Children between the ages of 3-59 months resident in the selected communities
* Children likely to be available for follow-up for 18 months
* Consent by parent/guardian of child

Exclusion Criteria:

* Chronic illness
* History of hypersensitivity to any of the study drugs

Answer: D