AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT01779128 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: MR-PET
Study NCT00998647 — intervention group
Intervention type: DEVICE
Intervention: modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus
Description: usage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids
Study NCT01519219 — intervention group
Intervention type: RADIATION
Intervention: Hepatic Irradiation
Description: Patients who take part in this study are required to be scheduled for hepatic irradiation. For the purposes of this research, they will undergo IC-GREEN testing within 2 weeks prior to the start of radiation therapy
Study NCT02589626 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: empagliflozin 10mg
Study NCT02589626 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: empagliflozin 25 mg
Study NCT02589626 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: For blinding purposes
Study NCT02946372 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: internal limiting membrane transplantation (ILMT)
Description: internal limiting membrane autologous transplantation (ILMT)
Study NCT03951883 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Increased Egg Consumption
Description: Subjects will be instructed to use a weekly food purchase supplement for inclusion of 2 additional eggs per day to be added to subject's typical daily diet.
Study NCT03951883 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Typical diet
Description: Subjects will be instructed to maintain their current dietary patterns.
Study NCT00885664 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Truvada (tenofovir/emtricitabine)
Description: Tenofovir/emtricitabine fixed dose combination once daily
Study NCT02430194 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ritonavir
Description: CYP 3A4 inhibitor, lonafarnib booster
Study NCT00349713 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: FMP2.1/AS02A
Description: FMP2.1 in GSK Biologicals' AS02A
Study NCT00349713 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: FMP2.1/AS02A
Description: FMP2.1 in GSK Biologicals' AS02A
Study NCT00349713 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Rabies vaccine (RabAvert)
Description: RabAvert Rabies vaccine
Study NCT02430194 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pegylated interferon-alfa-2a
Description: immunomodulator
Study NCT01592318 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: danoprevir
Description: Fixed dose combination tablet with ritonavir, single oral dose
Study NCT01592318 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: danoprevir
Description: Reference tablet, single oral dose
Study NCT01592318 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ritonavir
Description: Fixed dose combination tablet with danoprevir, single oral dose
Study NCT01592318 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: ritonavir
Description: Reference tablet, single oral dose
Study NCT00726726 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan)
Description: Capsules + Tablets + Oral solution, Oral, Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg once daily, Day 1, 1 Day
Study NCT00726726 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BMS-708163
Description: Capsules, Oral, 150 mg, once daily, days 6-15, 10 Days
Study NCT00726726 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BMS-708163 + Cooperstown Cocktail
Description: Capsules + tablets + Oral solution, Oral, BMS-708163: 150 mg + Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg, BMS-708163, once daily, days 16-20 midazolam,warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan once daily on Day 16, 5 Days
Study NCT01190592 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Resistance Training with Milk Supplementation in Adolescents
Description: On resistance training days, the RT+ milk group will receive milk (280kcals) immediately following exercise and milk at another time during the day. The RT+ juice group will receive fruit juice immediately following resistance exercise and juice again another time during the day. The RT+ water group will receive water following resistance exercise and water at another time during the day.~On non training days, students in the RT+ milk group will receive milk. Students in the RT+ juice group will receive juice. The RT+ water group will receive water during the school day. On non-RT days, the total volume of milk, juice, or water will be split into two administration times during the school day.
Study NCT01190592 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Resistance Training with Milk Supplementation in Adolescents
Description: On resistance training days, the RT+ milk group will receive milk (280kcals) immediately following exercise and milk at another time during the day. The RT+ juice group will receive fruit juice immediately following resistance exercise and juice again another time during the day. The RT+ water group will receive water following resistance exercise and water at another time during the day.~On non training days, students in the RT+ milk group will receive milk. Students in the RT+ juice group will receive juice. The RT+ water group will receive water during the school day. On non-RT days, the total volume of milk, juice, or water will be split into two administration times during the school day.
Study NCT03717961 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BOTOX® solution
Description: Botox solution + Saline serum + lidocaine/prilocaine cream + Nitrous oxide/oxygen (50%/50%)
Study NCT03717961 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo group
Description: Placebo + lidocaine/prilocaine cream + Nitrous oxide/oxygen (50%/50%)
Study NCT02019368 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study NCT02019368 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Aged garlic extract
Study NCT03781752 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylphenidate
Description: study to determine dose
Study NCT03762473 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Study Group
Description: Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.
Study NCT03762473 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Control Group
Description: Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of \< 1 at month 1, and BK data available and month 2,3, 6,9,12.
Study NCT00636610 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vismodegib 150 mg
Description: Vismodegib 150 mg was provided in hard gelatin capsules in 3 different strengths, 25 mg, 125 mg, and 150 mg.
Study NCT00636610 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo to vismodegib
Description: Placebo to vismodegib consisted of the excipients for vismodegib without the active molecule in hard gelatin capsules matching the active drug product in color and size.
Study NCT00636610 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Bevacizumab
Description: Bevacizumab 5 mg/kg was administered intravenously (IV) over 90 minutes for the first infusion, shortening to 60 and 30 minutes for subsequent infusions.
Study NCT00636610 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Description: Bevacizumab 5 mg/kg was administered intravenously (IV) over 90 minutes for the first infusion, shortening to 60 and 30 minutes for subsequent infusions.
Study NCT00636610 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Modified FOLFOX
Description: Following administration of bevacizumab, patients received oxaliplatin 85 mg/m\^2 IV administered over 90 minutes concurrently with folinic acid 400 mg/m\^2 (d,I-racemic form, or 200 mg/m\^2 I-isomer form) IV administered over 120 minutes, then fluorouracil 400 mg/m\^2 administered as an IV bolus, then 2400 mg/m\^2 administered as a continuous IV infusion over 46 hours.
Study NCT00636610 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Modified FOLFOX
Description: Following administration of bevacizumab, patients received oxaliplatin 85 mg/m\^2 IV administered over 90 minutes concurrently with folinic acid 400 mg/m\^2 (d,I-racemic form, or 200 mg/m\^2 I-isomer form) IV administered over 120 minutes, then fluorouracil 400 mg/m\^2 administered as an IV bolus, then 2400 mg/m\^2 administered as a continuous IV infusion over 46 hours.
Study NCT00636610 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: FOLFIRI
Description: Following administration of bevacizumab, patients received irinotecan 180 mg/m\^2 IV administered over 90 minutes concurrently with folinic acid 400 mg/m\^2 (d,I-racemic form, or 200 mg/m\^2 I-isomer form) administered IV over 120 minutes, then fluorouracil 400 mg/m\^2 administered as an IV bolus, then fluorouracil 2400 mg/m\^2 administered as a continuous IV infusion over 46 hours.
Study NCT00636610 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FOLFIRI
Description: Following administration of bevacizumab, patients received irinotecan 180 mg/m\^2 IV administered over 90 minutes concurrently with folinic acid 400 mg/m\^2 (d,I-racemic form, or 200 mg/m\^2 I-isomer form) administered IV over 120 minutes, then fluorouracil 400 mg/m\^2 administered as an IV bolus, then fluorouracil 2400 mg/m\^2 administered as a continuous IV infusion over 46 hours.
Study NCT00885664 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Kaletra (lopinavir/ritonavir)
Description: Lopinavir/ritonavir 400/100 mg twice daily
Study NCT02962908 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: FLU-v
Description: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH
Study NCT02962908 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: adjuvanted FLU-v
Description: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection
Study NCT02962908 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Saline
Description: Subcutaneous injection in the upper arm with 0.5ml of saline
Study NCT02962908 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Saline
Description: Subcutaneous injection in the upper arm with 0.5ml of saline
Study NCT02962908 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Adjuvanted placebo
Description: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection
Study NCT01308242 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sevelamer Carbonate
Description: Sevelamer 800 mg by mouth three times daily with meals for 3 months
Study NCT02666547 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: 68Ga-NODAGA-RGD PET/CT
Description: 200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images acquired on all body . For glioma, images acquired centred on the skull
Study NCT02666547 — intervention group
Intervention type: RADIATION
Group type: OTHER
Intervention: 18F-FDG PET/CT
Description: 3.5 MBq/kg 18F-FDG will be administered i.v. and images acquired on all body
Study NCT02666547 — intervention group
Intervention type: RADIATION
Group type: OTHER
Intervention: 18F-FET PET/CT
Description: 200 MBq 18F-FET will be administered i.v. and images acquired centred on the skull
Study NCT03526822 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Blood sample
Description: Five blood sample in pre-, post-operative period, before radiotherapy, before adjuvant temozolomide and at relapse in newly diagnosed glioblastoma
Study NCT03526822 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Tumor sample
Description: One tumor sample in operative period
Study NCT03662204 — intervention group
Intervention type: OTHER
Intervention: Blood Sample Collection
Description: Subjects participating in the study will have blood drawn at enrollment.
Study NCT01384994 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Folic Acid
Description: 400 mg/m2, 2h infusion, d1, q2w
Study NCT01384994 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-FU
Description: 400 mg/m2 bolus iv, d1, q2w
Study NCT01384994 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-FU
Description: 2400 mg/m2 46-h infusion, d1-2, q2w
Study NCT01384994 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Description: 85 mg/m2 d1, q2w
Study NCT01384994 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Panitumumab
Description: 6 mg/kg BW every 2 weeks
Study NCT01384994 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Panitumumab
Description: Panitumumab maintenance phase (3 months) 9mg/kg BW every 3 weeks
Study NCT01384994 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Folic Acid
Description: 400 mg/m2, 2-h infusion, d1, q2w
Study NCT03097458 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Short-term Counselling for Families
Description: Counselling for Families which can take up to 6 weeks, with regular meetings under the guidance of a trained psychotherapist.
Study NCT03852875 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Education
Description: Same
Study NCT01384994 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 5-FU
Description: 400 mg/m2 bolus iv, d1, q2w
Study NCT01384994 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 5-FU
Description: 2400 mg/m2 46-h infusion, d1-2, q2w
Study NCT01384994 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxaliplatin
Description: 85 mg/m2 d1, q2w
Study NCT02395939 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: CT guided core biopsy
Description: CT guided biopsy will be performed by a trained interventional radiologist using core biopsy.
Study NCT02395939 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Cryo-biopsy via Radial EBUS navigation
Description: Cryo-biopsy will be performed via R-EBUS guidance. Cryo biopsy probe will be applied for 4 seconds for each biopsy and a minimum of 3 biopsies will be performed . Each patient will also have 3 forceps biopsies. The order of forceps biopsy or cryo biopsy will be randomly allocated.
Study NCT00829387 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: CBT plus standard pharmaceutical care (CBT/SC)
Description: Ten sessions of individual treatment delivered by a doctoral level psychologist.
Study NCT00829387 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Diabetic Education plus standard pharmaceutical care (ED/SC)
Description: Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator.
Study NCT02275676 — intervention group
Intervention type: OTHER
Intervention: bioelectrical impedance analysis
Study NCT01521286 — intervention group
Intervention type: OTHER
Intervention: Data collection
Description: HZ and PHN booklet questionnaire and zoster brief pain inventory (ZBPI) questionnaire.
Study NCT02275676 — intervention group
Intervention type: OTHER
Intervention: indirect calorimetry
Study NCT02304861 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Viscoat
Description: Cataract extraction surgery performed with the Alcon Infiniti VisionSystem platform. Pupils were dilated with Tropicamide 0.5% (Tropixal, Demo, Greece) and Phenylephrine Hydrochloride 5% (Phenylephrine, Cooper, Greece). Periorbital skin and the lids were cleaned and the conjuctival cul-de-sac was irrigated with povidone iodine (Betadine). Patients received topical anesthesia with propacaine hydrochloride 0.5% drops (3 drops prior to surgery). By means of a 2.75mm, superior-temporal (eleven o'clock), self-sealing, clear-cornea incision 3% Sodium Hyaluronate, 4% Chondroitin Sulfate (Viscoat, Alcon, Greece) was injected in the anterior chamber
Study NCT00990691 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Administration of a high dose of desipramine
Description: Administration of a daily dose of desipramine correlated with the patient's weight :~* From 15 to 25 kg : 50 mg ;~* From 26 to 35 kg : 75 mg ;~* From 36 to 45 kg : 100 mg ;~* > 46 kg : 150 mg.
Study NCT00990691 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Administration of a low dose of desipramine
Description: Administration of a daily dose of desipramine correlated with the patient's weight :~* From 15 to 25 kg : 25 mg ;~* From 26 to 35 kg : 50 mg ;~* From 36 to 45 kg : 75 mg ;~* > 46 kg : 100 mg.
Study NCT02304861 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Visthesia
Description: Cataract extraction surgery performed with the Alcon Infiniti VisionSystem platform. Pupils were dilated with Tropicamide 0.5% (Tropixal, Demo, Greece) and Phenylephrine Hydrochloride 5% (Phenylephrine, Cooper, Greece). Periorbital skin and the lids were cleaned and the conjuctival cul-de-sac was irrigated with povidone iodine (Betadine). Patients received topical anesthesia with propacaine hydrochloride 0.5% drops (3 drops prior to surgery). By means of a 2.75mm, superior-temporal (eleven o'clock), self-sealing, clear-cornea incision sodium hyaluronate 1.5% and lidocaine hydrochloride 1% ophthalmic viscosurgical device (OVD) (Visthesia, Carl Zeiss, Germany) was injected in the anterior chamber
Study NCT02744430 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mirabegron
Description: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
Study NCT02744430 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
Study NCT01905020 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Carbohydrate-rich meal
Description: At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females). Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
Study NCT01905020 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise
Description: Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve. The workout will be on a treadmill and/or a stationary bicycle. Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
Study NCT00990691 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Administration of a placebo
Description: Administration of a daily dose of placebo
Study NCT00313820 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pregabalin
Description: Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.
Study NCT00313820 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.