AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT04563533 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: High-dose vaccine
Description: Active ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoV GII.4-VP1 protein and recombinant ReNoV GII.17-VP1 protein each 25μg.~Other ingredients: aluminum hydroxide adjuvant 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.
Study NCT01424189 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Description: Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Study NCT01424189 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Description: Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
Study NCT04563533 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (containing aluminum)
Description: Active ingredients: none Other ingredients: aluminum hydroxide adjuvant: 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.
Study NCT04563533 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo (containing aluminum)
Description: Active ingredients: none Other ingredients: aluminum hydroxide adjuvant: 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.
Study NCT04563533 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (without aluminum)
Description: Active ingredients: none Other ingredients: L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.
Study NCT01988948 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Various biological sampling
Study NCT01262326 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Calorie and Carbohydrate Restriction
Description: Carbohydrate Restriction = \<20 g/d of dietary carbohydrate intake Calorie Restriction = 1200 kcal/d for women and 1500 kcal/d for men
Study NCT01262326 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Calorie and Carbohydrate Restriction
Description: Carbohydrate Restriction = \<20 g/d of dietary carbohydrate intake Calorie Restriction = 1200 kcal/d for women and 1500 kcal/d for men
Study NCT02872948 — intervention group
Intervention type: GENETIC
Intervention: Diagnostic
Study NCT04573725 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TS-142
Description: Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)
Study NCT04573725 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Dose-matched Placebo to TS-142
Description: Participants received single dose-matched placebo to TS-142 (oral capsule)
Study NCT04748016 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 3D printed (3DP) bone models + CT imaging
Description: In addition to CT-MPR and CT-3DR, 3DP models will be used for surgical planning and intraoperative visualization.
Study NCT04748016 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: CT imaging
Description: CT-MPR and CT-3DR used for surgical planning and intraoperative visualization.
Study NCT01644201 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: PolyGlycopleX® - PGX®
Description: 15g or 20g total daily dose, 5g pre-mixed with liquid meal replacement and consumed twice daily, 5g supplement granules sprinkled on food and consumed once of twice daily
Study NCT01644201 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Rice Flour (placebo)
Description: 15g or 20g total daily dose, 5g pre-mixed with liquid meal replacement and consumed twice daily, 5g supplement granules sprinkled on food and consumed once of twice daily
Study NCT01949233 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irbesartan 150-300mg capsules daily for 6 months
Study NCT01949233 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxycycline 100-200mg capsules daily for 6 months
Study NCT01949233 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxycycline placebo capsules daily for 6 months
Study NCT01949233 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Doxycycline placebo capsules daily for 6 months
Study NCT01949233 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irbesartan placebo capsules daily for 6 months
Study NCT01949233 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Irbesartan placebo capsules daily for 6 months
Study NCT01453348 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: MenACWY-CRM
Description: Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.
Study NCT01453348 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Combined inactivated hepatitis A & recombinant hepatitis B
Description: Combined inactivated hepatitis A and recombinant hepatitis B vaccine will be administered by IM on days 1, 8 \& 29 for subjects unprimed with hepatitis A and B; and a single booster injection on day 1 for primed subjects.
Study NCT01453348 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Recombinant hepatitis B vaccine
Description: Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29
Study NCT01453348 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Inactivated hepatitis A vaccine
Description: Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.
Study NCT01673893 — intervention group
Intervention type: DEVICE
Intervention: ClearWay™ Rx catheter
Study NCT04821128 — intervention group
Intervention type: OTHER
Intervention: Radiologic and pathological review.
Description: We will analyse the pre operative scannographic and MRI (if available) images, and the post operative pathological analyses.~The scanners will be reviewed by 2 well trained clinicians (one head and neck radiologist and one head and neck surgeon).~Then we will analyse the correlation between the radiological and the pathological analysis.
Study NCT03221101 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Home ventilator
Study NCT03763916 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Ureteric dissection
Description: clamping and cutting the round ligament, clamping and cutting the ovarian ligament with ovarian preservation, careful dissection and clamping of the broad ligament varicosities, careful dissection of the post leaflet of the broad ligament until ureter is reached, careful dissection and exposure of both ureter and proper identification of the iliac vessels
Study NCT04170166 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Posterior subacromial steroid injection
Description: Applying to the posterior approach arm, this group will receive their subacromial steroid injection via an posterior approach
Study NCT01589536 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: interval-rehabilitation
Description: The Patients in the intervention group receive a Stationary psychocardiological interval-rehabilitation.The Interval rehabilitation is divided into individual psychological therapy with focus of Behavior therapy and relaxation therapy.
Study NCT03019393 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Beef
Description: 200 g beef topside which is fully cooked will be provided to participant after overnight fast. The intervention is one time only.
Study NCT01310088 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Lifestyle intervention
Description: Treatment protocol. The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark
Study NCT00378508 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mAb hOKT3gamma1(Ala-Ala), Teplizumab
Description: This is a randomized, two-arm, double blind placebo controlled phase II trial in which 60 participants with recent-onset T1DM are randomized at a 1:1 ratio to receive Teplizumab or placebo over a 14 day treatment period. The course of Teplizumab comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2.
Study NCT00378508 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Arm
Study NCT04482998 — intervention group
Intervention type: OTHER
Intervention: No intervention - retrospective study
Description: No intervention - retrospective study
Study NCT03763916 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Preoperative ureteric stenting
Description: preoperative insertion of ureteric catheters is performed by the urologist in our team just before the start of cesarean hysterectomy. Patient is positioned in lithotomy, cystoscopy \[Karl storz\] is done to identify the ureteric orifices. ureteric catheters \[Roche\] are inserted followed by the insertion of Foley's urethral catheter
Study NCT03763916 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Cesarean hysterectomy
Description: lateral dissection of the uterus is completed from the pelvic side wall, followed by very CAREFUL BLADDER DISSECTION. Finally clamping of the uterine vessels is done below the level of the placenta with or without complete removal of the cervix. Closure of the uterine stump is performed followed by CAREFUL HEMOSTASIS then closure of the abdomen is performed after leaving two wide bore drains
Study NCT02319070 — intervention group
Intervention type: OTHER
Intervention: Survey
Description: Recombinant antihemophilic factor VIII (FVIII) on Secondary Prophylaxis treatment scheduled according to daily routine
Study NCT03628339 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Midazolam
Description: Participant received single oral dose of 7.5 mg midazolam tablet on Day 1 of treatment period 1 and Day 11 in treatment period 2.
Study NCT03628339 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tepotinib
Description: Participants received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 in treatment period 2.
Study NCT03360851 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: low-dose CT
Description: see arm/group description
Study NCT03360851 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: PoC-PCR
Description: see arm/group description
Study NCT02319070 — intervention group
Intervention type: OTHER
Intervention: Survey
Description: Recombinant antihemophilic factor VIII (FVIII) On Demand treatment scheduled according to daily routine
Study NCT03154463 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: TAP Blocks
Description: TAP blocks were performed using ultrasound as a guide and injected on three points on trans abdominal plane using 100 mm stimuplex needle and 0.25% bupivacaine with total volume of 20 ml in each point (with total of 60 ml in three points)
Study NCT03154463 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: continuous epidural infusion
Description: Continuous epidural infusion was given with epidural regimen of 0.25% bupivacaine without any adjuvant
Study NCT00904891 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Cognitive-behavioral group
Description: Six sessions of cognitive-behavioral depression prevention group intervention
Study NCT00904891 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cognitive-behavioral bibliotherapy
Description: Cognitive-behavioral bibliotherapy, delivered from the book Feeling Good
Study NCT01364597 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Brivaracetam (BRV)
Description: The max BRV dose will be 5.0 mg/kg/day, not to exceed a dose of 200 mg/day for subjects with body weight >40kg. Subjects may receive oral solution or oral tablets. The LTFU subjects will start dosing in N01266 on the individualized BRV dose they were receiving at the completion of the core study. Subjects must be able to tolerate the min BRV dose specified in the core study to be eligible for entry into the Evaluation Period of N01266. Dose can be adjusted as considered necessary by the Investigator and required by the subject's medical condition. All subjects who prematurely discontinue the study should complete an EDV and have their BRV dose down titrated by a maximum of half the dose every week for a maximum of 4 weeks until a dose of 1 mg/kg/day (50 mg/day for subjects with body weights >50kg) is reached.
Study NCT04266639 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Remote Ischemic Conditioning
Description: RIC is commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion
Study NCT04266639 — intervention group
Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Sham Remote Ischemic Conditioning
Description: Sham Comparator (Sham-RIC)
Study NCT04458623 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Air Test
Description: .The Air-Test may represent an accurate, simple, inexpensive and non-invasive method for diagnosing postoperative atelectasis.
Study NCT02877810 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Telemedicine
Description: Telemedicine is a live, interactive, audiovisual teleconferencing system.
Study NCT02877810 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Telephone
Description: Consultations will be given over telephone.
Study NCT03843749 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pyrotinib
Description: Pyrotinib in Combination With Trastuzumab
Study NCT01598090 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Peginterferon Lambda-1a
Description: Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response
Study NCT04078360 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: AMBIT (Alcohol use disorders- mobile based Brief Intervention treatment) intervention
Description: The intervention will consist of participants receiving messages and/IVR calls not more than twice or thrice a week on their mobile phone for a duration of 8 weeks. Messages/IVR calls will be sent through VIAMO's technology platform. Each week messages will be focussed on specific content areas derived from the formative research of the study. Some of the components of the intervention include:~1. Self awareness messages~2. Self reflection messages~3. Motivational messages~4. Messages on safe drinking, alcohol reduction, drinking management, risk management, craving management and drinking alternatives.~5. Health education messages~6. Personalized feedback and information~7. Help-seeking resources~8. Goal setting messages
Study NCT04078360 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Face to face Brief Intervention
Description: The intervention will consist of the participants receiving the BI based on the WHO Mental Health Gap Action Programme (mhGAP) intervention from a trained researcher. The BI will be conducted over a single session (5-10 mins).
Study NCT04078360 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: BI leaflet intervention
Description: The intervention will consist of an educational BI leaflet consisting of health information on alcohol consumption, and tips to manage and reduce drinking.
Study NCT01598090 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Peginterferon Alfa-2a
Description: Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response
Study NCT01949103 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TD-1607
Study NCT01598090 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ribavirin
Description: Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response
Study NCT01598090 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Telaprevir
Description: Tablets, Oral, 750 mg, three times a day, 12 weeks only
Study NCT01949103 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Study NCT03379753 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: music and positive images
Description: The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room.
Study NCT04173767 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: high flow nasal cannula ventilation
Description: High-flow nasal cannula (HFNC) ventilation therapy: supply heated \& humidified air up to 60 L/min of flow; effects: positive end expiratory pressure effect, humidification.
Study NCT01423786 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: Early Oral Nutrition
Description: Once enrolled in the study, patients will be allowed a oral diet that is low in fat.
Study NCT00113360 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RAD001
Description: Starting dose of 5 or 10 mg by mouth daily.
Study NCT00113360 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Octreotide Depot
Description: 30 mg injection into the muscle of either buttock once every 28 (±7) days.
Study NCT02481375 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Multiple micronutrients
Description: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine
Study NCT02481375 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Multiple micronutrients
Description: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine
Study NCT01024868 — intervention group
Intervention type: DRUG
Intervention: Ropivacaine 0,5%
Description: Injection of ropivacaine 0,5% 20 ml bilaterally before surgery
Study NCT02481375 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Iron
Description: 12-wk supplementation of iron
Study NCT02481375 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Iron
Description: 12-wk supplementation of iron
Study NCT02481375 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 12-wk supplementation of placebo
Study NCT05134350 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LOXO-305
Description: LOXO-305 orally.
Study NCT05134350 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Omeprazole
Description: Omeprazole Orally.
Study NCT00910208 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Patient-controlled analgesia
Description: Intravenous morphine delivered via Curlin painsmart PCA device
Study NCT00910208 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: morphine
Description: Intravenous morphine
Study NCT00910208 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: morphine
Description: Intravenous morphine
Study NCT02568020 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: keto-amino acids
Description: Ketosteril®( Fresenius Kabi) will be given at a dosage of one tablet/5kg ideal body weight/day, divided into three doses taken during meals.The patients will be followed-up for one year. The patients will come to the hospital every 4 weeks.
Study NCT02244463 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MLN0128
Study NCT03690830 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: metabolomics analysis
Description: collect blood samples and endometrial cells
Study NCT03690830 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: metabolomics analysis
Description: collect blood samples and endometrial cells
Study NCT01356316 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AdimFlu-S Vaccine 2010-2011
Description: Per ml contains following strains 30μg, A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008
Study NCT00353613 — intervention group
Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Package of targeted interventions to reduce error
Description: Interventions will include changes in administration of antibiotics and the improved monitoring of blood glucose and body temperature peri-operatively.
Study NCT01605760 — intervention group
Intervention type: DRUG
Group type: NO_INTERVENTION
Intervention: immunotherapy Staloral
Description: Staloral (R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. During a 16 day incrementally increasing dose period, patients took daily increasing doses period, patients took 1-8 drops of the 100 IR/ml extract during the first 8 days. Then, on days 9-16, patients took 1-8 drops of the 300 IR/ml extract. Next, patients received maintenance treatment consisting of five applications of eight drops (equivalent to 0.5 mL) of 300 IR/mL extract five times a week. The mean duration of the treatment was 28.2 months (range: 3-36 months).
Study NCT01605760 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: immunotherapy Staloral
Description: Staloral (R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. During a 16 day incrementally increasing dose period, patients took daily increasing doses period, patients took 1-8 drops of the 100 IR/ml extract during the first 8 days. Then, on days 9-16, patients took 1-8 drops of the 300 IR/ml extract. Next, patients received maintenance treatment consisting of five applications of eight drops (equivalent to 0.5 mL) of 300 IR/mL extract five times a week. The mean duration of the treatment was 28.2 months (range: 3-36 months).
Study NCT03351738 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MEDI5884
Description: Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.