TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03111030

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: ProacTive SCI
Description: Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:~1. An assessment of motivated the participant is to be physically active~2. A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.~   B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.~3. Progress and barriers will be reassessed and discussed.
Study: NCT03783871

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Microwave ablation
Description: Subjects will be treated with microwave ablation.
Study: NCT04447755

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenvatinib
Description: Lenvatinib capsules administered orally at 14 mg/m\^2 QD
Study: NCT02918747

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: 800mg/m2, ivd on day 1 and 5 of each 21 day cycle. Number of Cycles: four.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Description: 85 mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: four

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: 15 mg, Ivd on day 1 to day 5 of each 21 day cycle. Number of Cycles: four.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclophosphamide
Description: 750 mg/m2，ivdrip day 1 of each 21 day cycle. Number of Cycles: four.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Doxorubicin
Description: 50mg/m 2，ivdrip day 1 of each 21 day cycle. Number of Cycles: four.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Vincristine
Description: 1.4 mg/m 2(≤2mg），ivdrip day 1 of each 21 day cycle. Number of Cycles: four.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prednisone
Description: 60 mg/m 2 /day orally on days1- 5 of each 21 day cycle. Number of Cycles: four.

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: IMRT
Description: After chemotherapy, if the patients get CR, PR or SD, IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50 -56grays (Gy) in 25-28 fractions.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: IMRT
Description: After chemotherapy, if the patients get CR, PR or SD, IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50 -56grays (Gy) in 25-28 fractions.
Study: NCT03719482

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [18F]MNI-1054
Description: Healthy Volunteers recruited for the study will undergo a single \[18F\]MNI-1054 injection and PET scan.
Study: NCT01778153

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Equinox Personal Coaching
Description: Specially designed strength and aerobic exercise training program that consists of 36 sessions over 12 weeks.
Study: NCT02883478

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: UV-X 1000 (3 mW/cm²)
Description: Ultraviolet-A (UVA) irradiation for 30 minutes at 3 milliwatt/cm² (mW/cm²).

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: UV-X 2000 (9 mW/cm²)
Description: Ultraviolet-A (UVA) irradiation for 10 minutes at 9 mW/cm².
Study: NCT02236728

Intervention type: DRUG
Intervention: Pramipexole
Study: NCT00628953

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Esomeprazole
Description: 40mg twice a day

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 40mg twice a day
Study: NCT02547636

Intervention type: OTHER
Intervention: Observational study
Description: No intervention will be used in this study.
Study: NCT01213368

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DRONEDARONE (SR33589)
Description: Pharmaceutical form: tablets~Route of administration: oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DRONEDARONE (SR33589)
Description: Pharmaceutical form: tablets~Route of administration: oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DRONEDARONE (SR33589)
Description: Pharmaceutical form: tablets~Route of administration: oral

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Pharmaceutical form: tablets~Route of administration: oral
Study: NCT04284020

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Therapeutic educational program
Description: See arm/group descriptions

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: PFMT
Description: See arm/group descriptions

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: PFMT
Description: See arm/group descriptions

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: TTNS
Description: See arm/group descriptions

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: TTNS
Description: See arm/group descriptions
Study: NCT01397305

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [6R] 5,10-methylenetetrahydrofolate (arfolitixorin)
Description: 10, 50, 100, 200, and 500 mg/m2 IV on day 1, day 8 day and day 15 of each 21-day cycle. 3 cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pemetrexed
Description: 500 mg/m2 IV on day 1 of each 21-day cycle. 3 cycles.
Study: NCT03796182

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Commercially available metformin (GLUCOPHAGE®) as 500 mg tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Commercially available metformin (GLUCOPHAGE®) as 500 mg tablets.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-04965842
Description: PF 04965842 100 mg tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-04965842
Description: PF 04965842 100 mg tablets
Study: NCT00736580

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Blunt tipped needle
Description: The Cesarean delivery is performed using blunt tipped needles.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Sharp needles
Description: The cesarean is performed using standard sharp surgical suture needles.
Study: NCT01492283

Intervention type: OTHER
Intervention: OGTT
Description: 50g waterfree glucose dissolved in 300 ml water consumed over 5 min.

Intervention type: OTHER
Intervention: OGTT
Description: 50g waterfree glucose dissolved in 300 ml water consumed over 5 min.

Intervention type: OTHER
Intervention: OGTT
Description: 50g waterfree glucose dissolved in 300 ml water consumed over 5 min.

Intervention type: OTHER
Intervention: OGTT
Description: 50g waterfree glucose dissolved in 300 ml water consumed over 5 min.

Intervention type: OTHER
Intervention: OGTT
Description: 50g waterfree glucose dissolved in 300 ml water consumed over 5 min.

Intervention type: OTHER
Intervention: IIGI
Description: iso glycemic intravenous (iv) glucose infusion (IIGI) with 20% glucose

Intervention type: OTHER
Intervention: IIGI
Description: iso glycemic intravenous (iv) glucose infusion (IIGI) with 20% glucose

Intervention type: OTHER
Intervention: IIGI
Description: iso glycemic intravenous (iv) glucose infusion (IIGI) with 20% glucose

Intervention type: OTHER
Intervention: IIGI
Description: iso glycemic intravenous (iv) glucose infusion (IIGI) with 20% glucose

Intervention type: OTHER
Intervention: IIGI
Description: iso glycemic intravenous (iv) glucose infusion (IIGI) with 20% glucose
Study: NCT02521961

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Informational Intervention
Description: Watch a Chair-robics DVD

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Informational Intervention
Description: Receive community resource booklet

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Quality-of-Life Assessment
Description: Ancillary studies

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Quality-of-Life Assessment
Description: Ancillary studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Questionnaire Administration
Description: Ancillary studies

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Support Group Therapy
Description: Attend support group sessions
Study: NCT04447755

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenvatinib
Description: Lenvatinib capsules administered orally at 14 mg/m\^2 QD

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenvatinib
Description: Lenvatinib capsules administered orally at 14 mg/m\^2 QD
Study: NCT02787642

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Olaparib
Description: Olaparib will be administered per os bidaily, as appropriate assigned dose level, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Concomitant Radiotherapy
Description: Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8.
Study: NCT00986427

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Restasis (cyclosporine ophthalmic emulsion) 0.05%
Description: cyclosporine ophthalmic emulsion 0.05%
Study: NCT02883478

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: riboflavin with hydroxypropyl methylcellulose
Description: Drops of riboflavin with hydroxypropyl methylcellulose will be applied in the eye for 20 minutes before ultraviolet-A(UVA) irradiation and every 2 minutes during UVA irradiation

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: riboflavin with hydroxypropyl methylcellulose
Description: Drops of riboflavin with hydroxypropyl methylcellulose will be applied in the eye for 20 minutes before ultraviolet-A(UVA) irradiation and every 2 minutes during UVA irradiation
Study: NCT00986427

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Refresh® Dry Eye therapy
Description: Emulsion contains glycerin 1% and polysorbate 80
Study: NCT01318772

Intervention type: DEVICE
Intervention: Radiography and Fluoroscopy Imaging System
Description: KALARE (DREX-KL80) is a new high resolution digital system designed for digital spot imaging, with the primary goal to address R/F and DSA clinical applications and produce images in a digital format.~The system includes a new digital camera and a new image processor.
Study: NCT03741920

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Personal KinetiGraph™ (PKG™)
Description: The Personal KinetiGraph™ (PKG™) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by Global Kinetics (GKC).~The Personal KinetiGraph™ (PKG™) Movement Recording System consists of the following:~* A wrist-worn data logger designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.~* An application to configure the data logger and transfer the acquired data at the end of a recording.~* A series of algorithms that analyze the uploaded data, producing a report that is delivered to the clinician. The report contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Personal KinetiGraph™ (PKG™)
Description: The Personal KinetiGraph™ (PKG™) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by Global Kinetics (GKC).~The Personal KinetiGraph™ (PKG™) Movement Recording System consists of the following:~* A wrist-worn data logger designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.~* An application to configure the data logger and transfer the acquired data at the end of a recording.~* A series of algorithms that analyze the uploaded data, producing a report that is delivered to the clinician. The report contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility.
Study: NCT02233205

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: ultrasonic microbubbles
Description: inject 1ml once and five times in 20min, locate the probe on the lesion at the same time

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: platinum and gemcitabine
Description: Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.
Study: NCT01353937

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: AMD3100 injection + rhPDGF-BB topical
Description: drug therapy to be given for the first 2 week duration given on a daily basis initiated during the first visit (Day 0).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: AMD3100 injection + rhPDGF-BB topical
Description: drug therapy to be given for the first 2 week duration given on a daily basis initiated during the first visit (Day 0).
Study: NCT05149248

Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: Gardasil® [Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant vaccine]
Description: HPV vaccination in an alternative schedule for MSM of 1 dose (M0).

Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: Two dose
Description: HPV vaccination in an alternative schedule for MSM of 2 doses over a 6-month period (M0,6)

Intervention type: OTHER
Group type: OTHER
Intervention: Control group
Description: HPV vaccination at 12 months

Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: 2 dose vaccination over 6 month
Description: 2-dose HPV vaccination regimen over a 6-month period (M0,6)

Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: 2 dose vaccination over 6 month
Description: 2-dose HPV vaccination regimen over a 6-month period (M0,6)

Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: 2 dose vaccination over 6 month
Description: 2-dose HPV vaccination regimen over a 6-month period (M0,6)

Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: 2 dose vaccination over 6 month
Description: 2-dose HPV vaccination regimen over a 6-month period (M0,6)
Study: NCT04574063

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Lifestyle intervention to reduce breast cancer risk
Description: Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Lifestyle intervention to reduce breast cancer risk
Description: Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Lifestyle intervention to reduce breast cancer risk
Description: Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Lifestyle intervention to reduce breast cancer risk
Description: Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.
Study: NCT02389673

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Intraoperative Radiotherapy
Description: Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Study: NCT01490762

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Technosphere Insulin Inhalation Powder using the Gen2C inhaler
Description: Inhalation Powder

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Regular Human Insulin
Description: Subcutaneous injection
Study: NCT02819895

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: A customized windows® software application
Description: A customized windows® software application with the ability to send automated voice call, SMS and email reminder about due dates for childhood routine immunizations.
Study: NCT01466322

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK2018682 CD2 Capsule; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed state
Description: Four single dosing sessions where each regimen A,B C or D will be administered orally in a randomised, cross-over manner. At each dosing session, pharmacokinetic sampling time-points will be the same.
Study: NCT00643071

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tacrolimus
Description: Oral
Study: NCT00585533

Intervention type: DRUG
Group type: OTHER
Intervention: Erlotinib (Tarceva)
Description: Erlotinib
Study: NCT01254188

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nilotinib
Description: This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.
Study: NCT04593914

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Cavilon Advanced Skin Protectant
Description: 3M™ Cavilon™ Advanced Skin Protectant is a polymeric-cyanoacrylate solution intended for the protection of intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier. It is elastomeric, adhering to the contours of the skin and providing a uniform film. The film is transparent and possesses good oxygen and moisture vapor permeability.~The polymer-cyanoacrylate is dispersed in a non-stinging solvent. The film is colorless, non-cytotoxic and has a low dermatitis potential. The film adheres to dry, moist or wet skin surfaces and remains intact during conditions of continuous or repeated exposure to moisture or caustic irritants. It will wear off the skin and does not require removal.
Study: NCT02033148

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: icotinib hydrochloride
Description: Given PO

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: Correlative studies
Study: NCT03009305

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Lower body negative pressure
Description: Model of hypovolemia: Lower body negative pressure down to -80 mmHg (maximum).

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Continuous positive airway pressure
Description: CPAP of 0, 5 and 10 cm water (H2O).

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Positive expiratory pressure
Description: PEP of 0, 5 and 10 cm H2O.
Study: NCT00740883

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: warfarin
Description: 18 months of warfarin therapy, once daily

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo of warfarin
Description: 18 months of placebo of warfarin therapy, once daily
Study: NCT01414712

Intervention type: OTHER
Intervention: Blood Drawing
Description: Blood Drawing to measure circulating tumor cells counts.
Study: NCT00738374

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rituximab [MabThera/Rituxan]
Description: 375mg/m2 iv on day 1 of course 3; 500mg/m2 iv on day 1 of courses 4-8 (induction phase); 375mg/m2 iv every 8 weeks (maintenance phase).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: chlorambucil
Description: 8mg/m2 po on days 1-7 of courses 1-8
Study: NCT00608439

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Centella asiatica selected triterpenes (CAST)
Description: Drug provided to subjects in 60 mg capsules. Dose escalation phase: subjects take 2 capsules/day for weeks 1-4, 3 capsules/day for weeks 4-8 and 4 capsules/day weeks 8-12. Subjects remain on highest tolerated dose from week 12 to 52.
Study: NCT01638858

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lucentis (Ranibizumab)
Description: Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry
Study: NCT03665948

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Dietary Intervention - Ketogenic Diet (KD)
Description: The experimental procedure for each randomly assigned participant included a 4-week of KD diet.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Dietary Intervention - Low-Glycemic Index Diet (CHO-LGI)
Description: The experimental procedure for each randomly assigned participant included a 4-week of CHO-LGI diet.
Study: NCT02999022

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lithium Carbonate
Description: Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Lactose Placebo
Description: Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.
Study: NCT03646435

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Fitbit Charge 2
Description: The Fitbit Charge 2 is the electronic wearable chosen for this pilot study. This particular Fitbit is capable of measuring patient heart rate, sleep and physical activity. The data collected will then be analyzed with respect to the outcomes of this study. To determine the accuracy of the Fitbit, data collected will be compared to the nurses' standard patient assessment (for HR and physical activity) and to patient responses on the Richards-Campbell Sleep Questionnaire (for sleep).
Study: NCT01812148

Intervention type: PROCEDURE
Intervention: Cytoreductive surgery and HIPEC
Description: Cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) with Oxaliplatin as chemotherapeutic agent
Study: NCT00608439

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: Placebo provided to subjects in 60 mg color-matched capsules. Dose escalation phase: subjects take 2 capsules/day for weeks 1-4, 3 capsules/day for weeks 4-8 and 4 capsules/day weeks 8-12. Subjects remain on highest tolerated dose from week 12 to 52.