TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02491008

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Levothyroxine
Description: The intervention will start with Levothyroxine 50 mcg daily (reduced to 25 mcg in subjects \<50 kg of body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) vs. matching placebo; at 3 months, if the serum TSH level is \<0.4 mU/L, dose will be reduced by 25 mcg; TSH \>=0.4 and \<4.6 mU/L, no change to dose; TSH \>=4.6 mU/L, additional 25 mcg. The process will be repeated at 12 months, then annually; mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine which will be prescribed is 150 mcg (after 4 increments of 25 mcg at 3 months, 1, 2, 3 years; from the starting dose of 50 mcg).
Study: NCT01590433

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Dietary counseling
Description: All subjects will also receive individualized dietary counseling. Subjects in the placebo group will be counseled to follow a hypocaloric diet.
Study: NCT01537926

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: N-acetylcysteine
Description: NAC 600mg capsule or matching Placebo , 1 twice daily for 90 days, then increase to NAC 1,200mg or matching placebo, 2 capsules twice daily for 270 days.
Study: NCT03607006

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Patient specific PEEK sheets
Description: Computer aided sheet design

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Autogenous bone shell
Description: autogenous retromolar/chin bone graft
Study: NCT02531022

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Financial incentive
Description: A daily financial incentive framed as a loss of $2 each day goal is not acheived

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Daily feedback
Description: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns
Study: NCT04287361

Intervention type: OTHER
Intervention: Efficacy of intravenous clonazepam
Description: Efficacy of intravenous clonazepam
Study: NCT02491008

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Control patients will obtain a placebo pill of the same characteristics as the intervention drug, and mock titration will be carried out identically to the intervention drug.~Pharmaceutical composition of placebo (100 mg): Lactose monohydrate 66 mg, Maize starch 25 mg, Gelatin 5 mg, Croscarmellose sodium 3.5 mg, Magnesium stearate (vegetable source) 0.5 mg.
Study: NCT02065531

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Myofascial Soft Tissue Release
Description: Protocol: Transverse Plane-Level Clavicular Release. Diaphragmatic Transverse Plane Release. Square the Lumbar Fascia Release. Gluteal Fascia Release. Hint Of Pubic Region Release. Fascia Psoas Release. Lumbo-sacral Decompression. Pelvic Floor Release.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Mobilization with impulse technique.
Description: Subject in lateral decubitus with extension and lower limb traction contact the couch with contralateral lower limb was performed triple flexion and left trunk rotation. This technique reduces the slack (tension joints) of the ventral pelvis, head and into the contralateral side of the sacrum support (base) with the forearm.
Study: NCT03077724

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fish oil
Description: Fish oil supplementation

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebos
Description: Olive Oil capsules
Study: NCT03204097

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Oral prophylaxis followed by placement of placebo gel

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Alendronate
Description: Oral prophylaxis followed by placement of Alendronate gel

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aloe Vera
Description: Oral prophylaxis followed by placement of Aloe Vera gel
Study: NCT00182754

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: octreotide acetate
Description: Given subcutaneously
Study: NCT01537926

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: sugar pill manufactured to minic NAC 600mg capsule
Study: NCT05859919

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: The drug Rutan 0.1.
Description: Active ingredient: (3,6-bis-O-galloyl-1,2,4-tri-O-galloyl-β-D-glucose). Active substance: Rutan 0.1 100mg. Excipients: potato starch, calcium stearate, lactulose.

Intervention type: OTHER
Group type: OTHER
Intervention: Basic treatment
Description: Basic treatment without the drug Rutan 0.1.
Study: NCT03741192

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: SPEAC System
Description: Surface Electromyography (sEMG) based seizure monitoring and alerting system
Study: NCT03478566

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Transcutaneous CO2 monitoring
Description: The aim is to assess the accuracy of ambulatory, at home, transcutaneous CO2 monitoring in pediatric Neuromuscular Disease (NMD).
Study: NCT00182754

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Given subcutaneously
Study: NCT01235468

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ex vivo expansion
Description: ex-vivo expansion of cord blood for transplantation
Study: NCT04666168

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Auto CAR-T
Description: Biological: Auto CAR-T

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide,Fludarabine
Description: Drug: Cyclophosphamide,Fludarabine

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Leukapheresis
Description: Leukapheresis
Study: NCT03877445

Intervention type: DEVICE
Group type: OTHER
Intervention: exposition half-face
Description: Patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control. The effect of blue light on the melasma lesions will be assessed from Day 1 to Day 6 using chromametry and a modified Melasma Area and Severity Index on standardized photographs

Intervention type: DEVICE
Group type: OTHER
Intervention: exposition half-face
Description: Patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control. The effect of blue light on the melasma lesions will be assessed from Day 1 to Day 6 using chromametry and a modified Melasma Area and Severity Index on standardized photographs
Study: NCT02580604

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Calcium Chloride/Calcium Gluconate
Description: Calcium (as either calcium chloride or calcium gluconate in half normal saline) will be delivered via IV during exercise to keep serum ionized calcium levels above baseline. The clamp is modeled after the hyperglycemic glucose clamp.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Saline Infusion
Study: NCT04622774

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGC936
Description: Antibody Drug Conjugate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGC936
Description: Antibody Drug Conjugate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGC936
Description: Antibody Drug Conjugate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGC936
Description: Antibody Drug Conjugate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGC936
Description: Antibody Drug Conjugate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGC936
Description: Antibody Drug Conjugate
Study: NCT04622774

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGC936
Description: Antibody Drug Conjugate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGC936
Description: Antibody Drug Conjugate
Study: NCT00612716

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: busulfan
Description: For those not eligible for total body irradiation: busulfan 4 mg/kg/day orally (1 mg/kg orally every 6 hrs) on Days -9 through -6.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cyclophosphamide
Description: Cyclophosphamide 60 mg/kg/day on days -7 and -6. For patients not eligible for total body irradiation: cytoxan 50 mg/kg intravenously (IV) on days -5 through -2.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Stem cell infusion
Description: Infused on Day 0

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Total body irradiation
Description: 165 cGy morning and evening on days -4 through -1.
Study: NCT03194789

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy
Description: Participants will have FGBMM using shoes with pertupods along with traditional pelvic floor therapy over the course of six months. This will include five sessions of gait assessment and re-calibration with daily at home exercise with the device (shoes) over the course of six months. Along with that, participant will receive traditional pelvic floor therapy of six sessions, up-to one sessions every alternate week. This will involve exercise and modalities as decided by medical providers and therapists. Participants will also have a home exercise program prescribed along with each session and for the remainder of six months.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Traditional Pelvic Floor Therapy
Description: Participant will receive traditional pelvic floor therapy of six sessions, up-to one sessions every alternate week. This will involve exercise and modalities as decided by medical providers and therapists. Participants will also have a home exercise program prescribed along with each session and for the remainder of six months.
Study: NCT03267069

Intervention type: OTHER
Intervention: survey
Description: surveys will be administered at inclusion and follow-ups
Study: NCT02116127

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Active tDCS
Description: The intervention is active 2mA transcranial direct current stimulation (tDCS). Direct current will be transferred with a pair of saline soaked sponge electrodes (contact area 5 x 7cm), and delivered for 30 minutes. The electrodes will be placed over F3 and F4 according to the 10-20 international system for EEG placement.

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Sham tDCS
Description: The sham intervention is transcranial direct current stimulation (tDCS). 2mA of direct current will be transferred with a pair of saline soaked sponge electrodes (contact area 5 x 7cm), and the current will be turned off after 54 seconds.The electrodes will be placed over F3 and F4 according to the 10-20 international system for EEG placement.
Study: NCT01107522

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CTO
Description: Oral administration daily for 28 day cycles; starting dose of CTO = 50 mg/m2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CTO and Temodar®
Description: Oral administration of CTO daily for 28 day cycles, starting dose of CTO = 219 mg/m2.~Temodar® administered orally at fixed dose of 150 mg/m2 daily for Days 1-5 in a 28 day cycle.~Expansion Cohort of 6 patients on fixed dose of 600mg CTO/day Temodar® administered orally at fixed dose of 150 mg/m2 daily for Days 1-5 in a 28 day cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CTO, Temodar®, Radiation therapy
Description: Oral administration of CTO daily for 28 day cycles; starting dose of CTO = 219 mg/m2 Temodar® administered orally at a dose of 75 mg/m2 daily during radiation therapy, then at 150mg/m2 for Days 1-5 of Cycle 1, and then up to 200 mg/m2 Days 1-5 of subsequent cycles Radiation: 3-dimensional conformal radiation therapy or, Radiation: intensity-modulated radiation therapy
Study: NCT03187730

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Integrated Smoking Cessation and Financial Counseling
Description: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Waitlist Integrated Smoking Cessation and Financial Counseling
Description: Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine Replacement Therapy (NRT)
Description: Participants in both arms will be eligible to receive a free four-week supply of NRT.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Nicotine Replacement Therapy (NRT)
Description: Participants in both arms will be eligible to receive a free four-week supply of NRT.
Study: NCT01659983

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Primary wound closure
Description: A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Primary wound closure
Description: A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge.
Study: NCT03048747

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tolvaptan Oral Tablet
Description: Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.
Study: NCT02801617

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PRO-067
Description: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: PRO-067
Description: 1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GAAP Ofteno®
Description: 1 drop QD during 30 days Active comparator, reference medication.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: GAAP Ofteno®
Description: 1 drop QD during 30 days Active comparator, reference medication.
Study: NCT00683618

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rosuvastatin
Description: Capsule/Tablet, oral, qd, 6 or 12 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rosuvastatin
Description: Capsule/Tablet, oral, qd, 6 or 12 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Atorvastatin
Description: Capsule/Tablet, 10mg, oral, qd, 6 weeks
Study: NCT03950414

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CMV specific T-cells
Description: Naturally occurring, allogeneic donor lymphocytes derived from a leukapheresis or a whole blood product, enriched for CMV-specific CD4+ and CD8+ T cells Suspension of CMV-specific T cells in 10 mL of 0.9% NaCl with 2% Human Serum Albumin(HSA) via IV bolus injection~* Low Dose Tier - Viral-Specific T cell infusion 5 x10\^3 cells/kg body weight(BW)~* Mid Dose Tier - Viral-Specific T cell infusion 1.25 x10\^4 cells/kg BW~* High Dose Tier - Viral-Specific T cell infusion 2.5 x10\^4 cells/kg BW Product will be administered fresh intravenously to recipient within four hours of collection.
Study: NCT02133560

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Video recording
Description: Subjects will be asked to monitor their daily iron chelator administration by taking a video recording of preparing it and ingesting at least one sip. The data collected will be analyzed to describe patient adherence and comfort level with the process of daily recording of medication management.

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Medication Administration Log
Description: Subjects will be asked to monitor their daily iron chelator administration by completing the medication administration log on a daily basis. The data collected will be analyzed to describe patient adherence and comfort level with the process of daily recording of medication management.

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Education
Description: During this first six months period a study staff member will see subjects at each scheduled clinic visit they attend for regular blood transfusion.~Subjects will receive educational material and short quizzes related to sickle cell disease, thalassemia, iron overload, or iron chelation.
Study: NCT03280524

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: reflexology

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: self-care guidelines with feet

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: self-care guidelines with feet
Study: NCT03385993

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Technology based guided meditation and relaxation
Description: Subjects will be guided through a mediation and relaxation exercise on a tablet or virtual reality headset for up to an hour each day.
Study: NCT02439541

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: UCMSC group
Description: Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10\^7)
Study: NCT02275819

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Exercise
Description: Exercise (walking 3 times a week for 60 minutes) or Inspiratory Muscle Therapy (breathing against an inspiratory resistive load 3 times a week for up to 60 minutes)
Study: NCT00921609

Intervention type: DIAGNOSTIC_TEST
Intervention: Oral glucose tolerance test
Description: An oral glucose tolerance test is a test that lowers growth hormone in the body to very low levels for a short time in order to see how low the growth hormone levels are in your blood.
Study: NCT00204919

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Vitamin D
Description: once-monthly vitamin D oral capsules (50,000 units)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: once-monthly placebo capsules
Study: NCT00954941

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ondansetron
Description: 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
Study: NCT02176512

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BIBR 277 SE and HCTZ
Description: Treatment A - fixed dose combination

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: BIBR 277 SE and HCTZ
Description: Treatment A - fixed dose combination

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BIBR 277 SE
Description: Treatment B - Monocomponent

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: BIBR 277 SE
Description: Treatment B - Monocomponent

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HCTZ
Description: Treatment B -Monocomponent

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: HCTZ
Description: Treatment B -Monocomponent
Study: NCT00954941

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ondansetron
Description: 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aprepitant
Description: 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
Study: NCT04622774

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IMGC936
Description: Antibody Drug Conjugate
Study: NCT01894841

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Coping Long Term with Active Suicide (CLASP)
Description: 6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Safety Assessment and Follow Up Evaluation
Description: enhanced risk monitoring with full assessment protocol at 3, 6, 9, and 12 month follow up. Results sent as a note to the patient's VA mental health provider

Intervention type: OTHER
Group type: OTHER
Intervention: Safety Assessment and Follow Up Evaluation
Description: enhanced risk monitoring with full assessment protocol at 3, 6, 9, and 12 month follow up. Results sent as a note to the patient's VA mental health provider
Study: NCT02531022

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Daily feedback
Description: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns
Study: NCT00435695

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: GSK163090
Study: NCT03307772

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Probiotics

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Prebiotics

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Prebiotics and Probiotics

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT01719367

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Atenolol
Study: NCT02019264

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lorcaserin hydrochloride
Description: APD356 10 mg twice daily

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo twice daily
Study: NCT02344238

Intervention type: OTHER
Group type: OTHER
Intervention: ID Capsule
Description: Capsule containing ingestible sensor

Intervention type: OTHER
Group type: OTHER
Intervention: ID Capsule
Description: Capsule containing ingestible sensor

Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: Riboflavin
Description: 50mg

Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: Riboflavin
Description: 50mg

Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: Riboflavin
Description: 50mg

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Prompts
Description: Reminder calls and/or text messages to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.
Study: NCT03289026

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aripiprazole
Description: Doses were flexibly titrated to between 10 and 30 mg once daily based on the individual needs of the patient as determined by the investigator.