TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01015144

Intervention type: DRUG
Intervention: Tulip
Description: Patients were divided into two groups: A, who were administered atorvastatin 40 mg daily for two months and 10 mg for next 4 months; and group B, 4 who were treated according to current guidelines without statin therapy.
Study: NCT02907580

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Local educational information
Description: Participants in this arm receive educational information regarding influenza vaccination based on local educational information.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: National educational information
Description: Participants in this arm receive educational information regarding influenza vaccination based on national educational information.
Study: NCT01578330

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fingolimod
Description: Fingolimod 0.5mg orally once a day without food.
Study: NCT01924507

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CPAP
Description: CPAP - continuous positive air pressure in patients with sleep apnea
Study: NCT01134731

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paliperidone
Description: 1-5 mg daily (QD)
Study: NCT02088086

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: BMI reporting
Description: Schools will send a report home to parents that provides their child's height, weight, and BMI results.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Fitness testing
Description: Students in grades 5-8 will participate in five fitness assessments (curl-ups, sit-ups, push-ups, sit-and-reach, and the PACER test or mile run) annually at school.
Study: NCT01134731

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: lithium
Description: 300-1500mg QD
Study: NCT02088086

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Fitness testing
Description: Students in grades 5-8 will participate in five fitness assessments (curl-ups, sit-ups, push-ups, sit-and-reach, and the PACER test or mile run) annually at school.
Study: NCT02248493

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paracetamol

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (for paracetamol)
Study: NCT01248624

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Early Palliative Care Referral
Description: The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Early Palliative Care Referral
Description: The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.
Study: NCT00850759

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: virtual pedestrian environment
Description: a computer-driven virtual pedestrian environment

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: computer and video
Description: various computer-based and video-based programs such as Otto the Auto and WalkSafe
Study: NCT02248493

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ketoprofen

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Ketoprofen

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tramadol
Description: Administered on request as rescue medication in a dose 2 mg/kg IV up till 2 doses. No other opioid is given to these patients.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Tramadol
Description: Administered on request as rescue medication in a dose 2 mg/kg IV up till 2 doses. No other opioid is given to these patients.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Morphine
Description: administered in patients receiving IV PCA with morphine postoperatively. No other opioid is given to these patients.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Morphine
Description: administered in patients receiving IV PCA with morphine postoperatively. No other opioid is given to these patients.
Study: NCT01134731

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 1-5 placebo capsules
Study: NCT03161093

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fasinumab
Description: Solution for injection in pre-filled syringe
Study: NCT02963220

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: CBT-AR
Description: 20-30 sessions of cognitive behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR), held once per week in an outpatient setting
Study: NCT01501630

Intervention type: DEVICE
Intervention: performance of PET/CT and whole-body MRI
Description: For PET/CT radiopharmaceuticals, both registered in France:Fluoride (18F)FLUOROCHOLINE (18F)No contrast agent scheduled for MRI in the study RadiopharmaceuticalsSingle use, 2-4 MBq/kg body weight, IV infusion
Study: NCT00741754

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Mouthrinse with HcT20
Description: Mouthrinse for 1 minute with 10ml, twice a day. During seven weeks
Study: NCT02964650

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Personalised rate-response settings
Description: Rate response range fixed to limits suggested by force-frequency curve
Study: NCT00603512

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 0 mg BID, 3 blinded tablets administered BID for 12 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CP-690,550
Description: 10 mg BID, 3 blinded tablets administered BID for 12 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CP-690,550
Description: 1 mg BID, 3 blinded tablets administered BID for 12 weeks
Study: NCT03161093

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fasinumab
Description: Solution for injection in pre-filled syringe

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Naproxen
Description: Pharmaceutical form: Capsule

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fasinumab-matching placebo
Description: Solution for injection in pre-filled syringe

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fasinumab-matching placebo
Description: Solution for injection in pre-filled syringe

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Naproxen-matching placebo
Description: Capsule

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Naproxen-matching placebo
Description: Capsule

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Naproxen-matching placebo
Description: Capsule
Study: NCT00751166

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Desloratadine
Description: Desloratadine 5 mg, oral tablet, once daily in the morning, 28 days

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cetirizine
Description: Cetirizine 10 mg, oral tablet (over encapsulated), once daily in the morning, 28 days
Study: NCT00850759

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: streetside training
Description: one-on-one training by an adult with the child at streetside locations, to teach children street-crossing skills
Study: NCT01849250

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docosahexaenoic Acid
Description: Given PO

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Given PO
Study: NCT03639883

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AIV001
Description: Intradermal injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AIV001
Description: Intradermal injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AIV001
Description: Intradermal injection
Study: NCT00868231

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aclidinium bromide 400 μg bid
Description: Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days.
Study: NCT00603512

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CP-690,550
Description: 3 mg BID, 3 blinded tablets administered BID for 12 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CP-690,550
Description: 5 mg BID, 3 blinded tablets administered BID for 12 weeks
Study: NCT04263233

Intervention type: OTHER
Intervention: Analysis using descriptive statistics of patient clinical outcomes.
Description: Evaluation of the following:~* Laboratory values at admission, week 4, and day 90.~* Pre and post blood pressure at week one and week 4.~* Intradialytic hypotension at week one and week 4.~* Ultrafiltration rates at week one, week 4, day 90, day 180, and day 360.~* Target weight defined and achievement in week one and week 4 and changes between week one and week 4.~* Dialysis access type at week one and day 90.~* Hospitalization and mortality rates.

Intervention type: OTHER
Intervention: Surveys with participants using validated survey tools.
Description: Surveys will assess participants' Symptom index, Quality of Life, Patient Activation as well as satisfaction with the program.

Intervention type: OTHER
Intervention: Evaluation of the program process including time, costs, referral rates, admission to the program and length of stay.
Description: Data will be collected using tracking tools throughout the program.
Study: NCT02221817

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Trochanter bursa injections

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Trochanter bursa injections

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Ultrasound
Study: NCT03537911

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Cognitive Support Program
Description: Three individual sessions of supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration), with practice applying program content between sessions.
Study: NCT00091286

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine
Study: NCT04556123

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopy
Description: The measurements will be performed in each center by a reference physician or nurse, using a portable whole body bioimpedance spectroscopy device, BCM (Fresenius Medical Care).~The electrodes will be attached to one hand and one foot on the ipsilateral side, after the patient has been in the supine position for at least 5 minutes.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Measurement of the hydration state and decongestive treatment according to clinical judgement alone
Description: Clinical judgement will be performed in each center by a reference physician or nurse
Study: NCT04181164

Intervention type: OTHER
Intervention: Microindentation
Description: Microindentation is a new technology directly measuring bone strength by a minimal invasive technique.

Intervention type: OTHER
Intervention: Microindentation
Description: Microindentation is a new technology directly measuring bone strength by a minimal invasive technique.

Intervention type: OTHER
Intervention: High resolution peripheral quantitative computed tomography (HRpQCT)
Description: HRpQCT scan can assess the cross-sectional geometry of the bone and is an appropriate investigation to evaluate bone quality.

Intervention type: OTHER
Intervention: High resolution peripheral quantitative computed tomography (HRpQCT)
Description: HRpQCT scan can assess the cross-sectional geometry of the bone and is an appropriate investigation to evaluate bone quality.

Intervention type: BIOLOGICAL
Intervention: Biochemical analysis of different bone markers.
Description: Measurement of different bone markers by biochemical analysis of blood samples.

Intervention type: BIOLOGICAL
Intervention: Biochemical analysis of different bone markers.
Description: Measurement of different bone markers by biochemical analysis of blood samples.
Study: NCT01231373

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: polidocanol injectable foam, 0.125%
Description: active placebo for blinding

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: polidocanol injectable foam, 0.5%
Description: 0.5% polidocanol foam injection
Study: NCT00751166

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: placebo once daily for 28 days
Study: NCT01298310

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Xylocaine
Description: 1 mg/mL solution for injection

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Xylocaine
Description: 10 mg/mL solution for injection

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: solution for injection
Study: NCT02927327

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Zero Echo Time (ZTE) scan for head attenuation
Description: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.~PET/MR ZTE MRAC
Study: NCT00868231

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tiotropium 18 μg once-daily
Description: Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days.
Study: NCT03639883

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AIV001
Description: Intradermal injection
Study: NCT00456963

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Diet
Description: total fat \< 5%, saturated fat \< 10%, vegetables, fruit

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Diet
Description: total fat \< 5%, saturated fat \< 10%, vegetables, fruit

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Diet
Description: total fat \< 5%, saturated fat \< 10%, vegetables, fruit

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Moderate exercise
Description: 30 min at least 5 times/week

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Moderate exercise
Description: 30 min at least 5 times/week

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Moderate exercise
Description: 30 min at least 5 times/week

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: enalapril tablets
Description: one Enalapril 10mg tablet once daily for four weeks. Subsequentely one Enalapril 20mg tablet once daily until the end of the randomized treatment phase

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo tablets
Description: one Enalapril placebo tablet and one Losartan placebo tablet once daily until study end.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Losartan Tablets
Description: one Losartan 50mg tablet once daily for four weeks. Subsequentely one Losartan 100mg tablet once daily until the end of the randomized treatment phase.
Study: NCT00367640

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 100 IR grass pollen allergen extract tablet
Description: One sublingual tablet daily during 4 months before pollen season and during pollen season

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 300 IR grass pollen allergen extract tablet
Description: One sublingual tablet daily during 4 months before pollen season and during pollen season

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 500 IR grass pollen allergen extract tablet
Description: One sublingual tablet daily during 4 months before pollen season and during pollen season
Study: NCT02684162

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Donor Lymphocytes
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Guadecitabine
Description: Given SC

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies
Study: NCT01323374

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Droxidopa
Description: Oral, 200mg, 400mg or 600mg TID, duration includes up to a 1 week blinded titration period followed by an 8 week treatment period.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Droxidopa
Description: Oral, 200mg, 400mg or 600mg TID, duration includes up to a 1 week blinded titration period followed by an 8 week treatment period.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Droxidopa
Description: Oral, 200mg, 400mg or 600mg TID, duration includes up to a 1 week blinded titration period followed by an 8 week treatment period.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Carbidopa
Description: Oral, 25mg, or 50mg TID, duration includes up to a 1 week blinded titration period followed by an 8 week treatment period.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Carbidopa
Description: Oral, 25mg, or 50mg TID, duration includes up to a 1 week blinded titration period followed by an 8 week treatment period.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Droxidopa/carbidopa
Description: Oral, 200mg/25mg, 400mg/25mg, 600mg/25mg, 200mg/50mg, 400mg/50mg, or 600mg/50mg TID. Duration includes up to a 1 week titration period followed by an 8 week treatment period.
Study: NCT00868231

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days.
Study: NCT02927327

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Q.Static (Q. MRAC) for respiratory motion correction
Description: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.~PET/MR Q Static (Q. MRAC)
Study: NCT03267303

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TS-091 5mg
Description: Orally taken once daily for 3 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TS-091 10mg
Description: Orally taken once daily for 3 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Orally taken once daily for 3 weeks
Study: NCT03120676

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Atezolizumab
Description: All patients will receive atezolizumab 1200 mg via IV infusion on D1 of each 21-day cycle.
Study: NCT01323374

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Droxidopa/carbidopa
Description: Oral, 200mg/25mg, 400mg/25mg, 600mg/25mg, 200mg/50mg, 400mg/50mg, or 600mg/50mg TID. Duration includes up to a 1 week titration period followed by an 8 week treatment period.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Droxidopa/carbidopa
Description: Oral, 200mg/25mg, 400mg/25mg, 600mg/25mg, 200mg/50mg, 400mg/50mg, or 600mg/50mg TID. Duration includes up to a 1 week titration period followed by an 8 week treatment period.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Droxidopa/carbidopa
Description: Oral, 200mg/25mg, 400mg/25mg, 600mg/25mg, 200mg/50mg, 400mg/50mg, or 600mg/50mg TID. Duration includes up to a 1 week titration period followed by an 8 week treatment period.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Droxidopa/carbidopa
Description: Oral, 200mg/25mg, 400mg/25mg, 600mg/25mg, 200mg/50mg, 400mg/50mg, or 600mg/50mg TID. Duration includes up to a 1 week titration period followed by an 8 week treatment period.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Droxidopa/carbidopa
Description: Oral, 200mg/25mg, 400mg/25mg, 600mg/25mg, 200mg/50mg, 400mg/50mg, or 600mg/50mg TID. Duration includes up to a 1 week titration period followed by an 8 week treatment period.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Oral, placebo TID
Study: NCT01498380

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine
Description: The bolus dose of dexmedetomidine given will range from 0.25-2.0 mcg/kg and will be based on the up-and-down method, such that subject 1 will receive 0.5 mcg/kg and if no significant hemodynamic changes occur (heart rate decrease \< 20% or blood pressure decrease/increase \< 20%) the does will be increased by 0.25 mcg/kg for the subsequent subject. If significant hemodynamic changes occur (HR decrease \>/= 20% or SBP/DBP/MAP decrease or increase \>/= 20%) the dose will be decreased by 0.25 mcg/kg for the subsequent subject. Each subject will be observed for 10 minutes following the dexmedetomidine bolus.
Study: NCT01044459

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aclidinium Bromide 200 µg
Description: aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aclidinium Bromide 400 µg
Description: aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
Study: NCT02430714

Intervention type: DRUG
Intervention: Lenvatinib
Description: 24mg once daily oral dosing to Unresectable thyroid cancer patients
Study: NCT00944840

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: SP plus amodiaquine
Description: SP plus amodiaquine or placebo at monthly interval during September, October and November
Study: NCT00367640

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo tablet
Description: One sublingual tablet daily during 4 months before pollen season and during pollen season
Study: NCT03306134

Intervention type: DIAGNOSTIC_TEST
Intervention: Dysphagia
Description: An overall assessment is going to be carry out by a multidisciplinary team during the visit.~Swallowing assessment is going to be performed during the visit. We are going to use: (i) the Eating Assessment Tool (EAT-10), which is a short 10-item, easy to use, self-administered questionnaire \[4\]. Although the EAT-10 is considered to be predominantly a questionnaire on FHS, some items on HR-QoL are also included. The sum score of this 10-item questionnaire ranges from 0 to 40, and (ii) the Sydney Swallowing Questionnaire (SSQ) to clinically assess the severity of the symptoms of dysphagia, if present.~All subjects are going to be submitted to the volume-viscosity swallow test (V- VST)

Intervention type: DIAGNOSTIC_TEST
Intervention: Dysphagia
Description: An overall assessment is going to be carry out by a multidisciplinary team during the visit.~Swallowing assessment is going to be performed during the visit. We are going to use: (i) the Eating Assessment Tool (EAT-10), which is a short 10-item, easy to use, self-administered questionnaire \[4\]. Although the EAT-10 is considered to be predominantly a questionnaire on FHS, some items on HR-QoL are also included. The sum score of this 10-item questionnaire ranges from 0 to 40, and (ii) the Sydney Swallowing Questionnaire (SSQ) to clinically assess the severity of the symptoms of dysphagia, if present.~All subjects are going to be submitted to the volume-viscosity swallow test (V- VST)
Study: NCT00944840

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: SP placebo plus amodiaquine placebo
Description: monthly treatment with amodiaquine and SP or placebo during September, October and November