TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01729767

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Acyclovir
Description: Patients who were randomly allocated to the Acyclovir group besides sticking with low salt diet will take the Acyclovir 400 mg pills for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day for the last 10 days. Patients would receive the medication in 2 sessions, first in the beginning of the study and the rest after 10 days. This way it would boost their compliance, and physicians would be aware of possible complications. Patients will report changes in their symptoms 10 days after initiating the drug and in 1, 3, and 6 month intervals. All changes in frequency and duration of vertigo attacks are recorded, and their tinnitus and aural fullness is recorded in a 0(with no symptom) to 4 (very severe) scale.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Participants who are randomly placed in placebo group, besides sticking with low salt diet will take the placebo (inert ingredient) for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day for the last 10 days. Patients would receive the medication in 2 sessions, first in the beginning of the study and the rest after 10 days. This way it would boost their compliance, and physicians would be aware of possible complications. Patients will report changes in their symptoms 10 days after initiating the drug and in 1, 3, and 6 month intervals. All changes in frequency and duration of vertigo attacks are recorded, and tinnitus and aural fullness is recorded in a 0(with no symptom) to 4 (very severe) scale.
Study: NCT02586155

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: Capsule manufactured to mimic RVX000222 100 mg capsule

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Atorvastatin
Description: High-Intensity Statin
Study: NCT01821599

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Nonaccelerated Rehabilitation
Description: Nonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 6 months of recovery.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Accelerated Rehabilitation
Description: Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 4 months of recovery.
Study: NCT02346786

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: eau minérale d'Aix-Les-Bains
Description: Sodium 0.44 mg Magnésium 2.25 mg Phosphore 0.003 mg Potassium 0.08 mg Calcium 8.23 mg Manganèse 0.0001 mg Fer 0.001 mg Cuivre 0.0005 mg Zinc 0.0005 mg Sélénium 1 µg Iode 0 µg

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: tap water
Study: NCT04874142

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: YYC506-T
Description: single administration

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: YYC506-A
Description: single administration

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: YYC506-T + YYC506-A
Description: concomotant administration

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: YYC506-A + YYC506-T
Description: concomotant administration
Study: NCT01714908

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Erlotinib w Concurrent Radiotherapy

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: etoposide/cis-platin (EP) w Concurrent Radiotherapy
Description: Etoposide / Cis-platin w Concurrent Radiotherapy
Study: NCT02064686

Intervention type: OTHER
Group type: NO_INTERVENTION
Intervention: Exhaled breath temperature
Study: NCT00567606

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Strength/Weight Training & Drug/Supplement
Description: G1 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week and strength/weight training exercises for upper and lower extremities and the spine.

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Drug/Supplement only
Description: G2 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week, but do not participate in strength/weight training exercises.
Study: NCT03607851

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lacosamide - conventional titration
Description: Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose at weekly intervals by 50 mg PO BID; up to 200 mg BID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lacosamide - rapid titration 1
Description: Administration of lacosamide by the following schedule, Initial: 100 mg PO BID Increase dose to 200 mg BID after one week

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lacosamide - rapid titration 2
Description: Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose every two days by 50 mg PO BID; up to 200 mg BID
Study: NCT03052517

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: QAW039 150 mg
Description: One tablet of QAW039 150 mg once daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: QAW039 450 mg
Description: One tablet of QAW039 450 mg once daily
Study: NCT00775333

Intervention type: PROCEDURE
Intervention: Outcome after carpal tunnel release
Description: Follow the outcome after standard carpal tunnel release in diabetic and non-diabetic patients
Study: NCT03052517

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: One tablet of Placebo once daily
Study: NCT01401712

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: ON-Q® Pain Relief System
Description: Identify insertion site lateral to paraspinous muscles and posteromedial to the rib fractures. Then, incise skin and soft tissue down to the level of the rib. Advance tunneler perpendicular to chest wall until it contacts the rib, then, advance superiorly at 45° angle in the extrathoracic space. Remove tunneler and advance catheter in space created. Attach catheter to pump filled with 0.2% ropivacaine at infusion rate of 2-12ml/hr.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Thoracic epidural catheter
Description: Introduce needle into the interspinous space of the vertebral column and advance into the epidural space. Advance the epidural catheter about 3-5 cm into the epidural space and remove the needle.
Study: NCT03369613

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: transcranial electrical stimulation
Description: The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: transcranial electrical stimulation
Description: The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: transcranial electrical stimulation
Description: The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: transcranial electrical stimulation
Description: The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: transcranial electrical stimulation
Description: The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: transcranial electrical stimulation
Description: The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.
Study: NCT01612897

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Computer based care reminders
Description: Physicians in the intervention clinic will receive computer generated reminders to screen for autism among children of appropriate age visiting the clinic.
Study: NCT03201159

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VLX103
Description: 150mg tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VLX103
Description: 150mg tablets

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: VLX103
Description: 150mg tablets
Study: NCT06423560

Intervention type: RADIATION
Intervention: Computed tomography
Description: Follow-up computed tomography at 3-6 months and 12 months

Intervention type: RADIATION
Intervention: Computed tomography
Description: Follow-up computed tomography at 3-6 months and 12 months
Study: NCT03549637

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Psychiatric population
Description: Genetic and biological analysis of patients
Study: NCT02347124

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Usual Care Control
Description: Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Enhanced Intervention
Description: Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
Study: NCT00482209

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Mifepristone, misoprostol
Description: 200mg mifepristone followed by 400mcg misoprostol 36-48 hours later

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: mifepristone, misoprostol
Description: 200mg mifepristone followed by 800mcg misoprostol 36-48 hours later
Study: NCT03965234

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Given via infusion

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Isolated Chemotherapeutic Lung Perfusion
Description: Undergo pulmonary suffusion
Study: NCT01424228

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Placebo matching tablet 2 mg once daily before breakfast for 24 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: prucalopride
Description: Prucalopride 2 mg daily before breakfast~1 mg for subjects \>65 years; in case of insufficient response 2 mg at week 2 or week 4
Study: NCT00509171

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Reamer Irrigator Aspirator
Description: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Reamer Irrigator Aspirator
Description: Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
Study: NCT04135846

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxazosin
Description: 16 mg or maximum tolerated dose (MTD)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Matching placebo
Study: NCT04588090

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: The concurrent 3 weeks TP regimen
Description: paclitaxel + cisplatin regimen (TP-TAX: 150mg/m\^2, DDP: 70mg/m\^2 (35mg/m\^2, d1, d2), 1 time/3 weeks) chemotherapy for 2 cycles.

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: The concurrent weekly TP regimen
Description: paclitaxel + cisplatin regimen (TP regimen: TAX 50mg/m\^2, DDP: 25mg/m\^2) 6 cycles of chemotherapy

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: External radiation plus intraluminal after-loading irradiation
Description: External radiotherapy of linear accelerator, CT simulation positioning, and intensity modulated radiotherapy will be applied for external radiotherapy. The prescribed dose is 95% PTV 45-50.8Gy/25-28 times (1.8Gy/time), the maximum and minimum in the target area do not exceed ±10% of the prescribed dose, and the increase in enlarged lymph nodes will reach 50-66GY. At the same time, the total dose of 192Ir high-dose rate intraluminal after-loading irradiation is 30-36Gy (EQD2: 40-48GY), and external pelvic irradiation is not available on the day of intraluminal after-loading irradiation.

Intervention type: RADIATION
Group type: PLACEBO_COMPARATOR
Intervention: External radiation plus intraluminal after-loading irradiation
Description: External radiotherapy of linear accelerator, CT simulation positioning, and intensity modulated radiotherapy will be applied for external radiotherapy. The prescribed dose is 95% PTV 45-50.8Gy/25-28 times (1.8Gy/time), the maximum and minimum in the target area do not exceed ±10% of the prescribed dose, and the increase in enlarged lymph nodes will reach 50-66GY. At the same time, the total dose of 192Ir high-dose rate intraluminal after-loading irradiation is 30-36Gy (EQD2: 40-48GY), and external pelvic irradiation is not available on the day of intraluminal after-loading irradiation.
Study: NCT04734587

Intervention type: DIAGNOSTIC_TEST
Intervention: Blood serum Neuron-specific Enolase measurement
Description: The Silent Brain Injury ratio was compared by measuring the Neuron-specific enzyme level with venous blood sampling from both patient groups before and after percutaneous coronary intervention.

Intervention type: DIAGNOSTIC_TEST
Intervention: Blood serum Neuron-specific Enolase measurement
Description: The Silent Brain Injury ratio was compared by measuring the Neuron-specific enzyme level with venous blood sampling from both patient groups before and after percutaneous coronary intervention.
Study: NCT04054466

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART
Description: It is a health intervention, performed by the nurse with the purpose of providing support or support to the patient's health care. The main objective of counseling is to improve adherence to treatment in patients who receive HAART but also consume alcoholic beverages.~The components of the differentiated counseling according to the levels of consumption are consolidated according to the recommendations given by the World Health Organization (WHO) after the application of the AUDIT:~Social consumption (sometime in life, in the last year or in the last month) = mainly education about consumer risks, its application will be bi-monthly.

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Habitual Counseling
Description: Regular counseling provided to patients receiving HAART, based on education and guidance to comply with antiretroviral treatment
Study: NCT02879578

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Valbenazine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Valbenazine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Valbenazine
Study: NCT00865839

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin HCl 500 mg tablets, single dose
Description: A: Experimental Subjects received Purepac formulated products under fasting conditions

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: CLUCOPHAGE® XR 500 mg tablets, single dose
Description: B: Active comparator Subjects received Bristol-Myers Squibb Company formulated products under fasting conditions
Study: NCT01426776

Intervention type: PROCEDURE
Group type: OTHER
Intervention: heart valve replacement
Description: The patients with heart valve disease and CSR will be received heart valve replacement
Study: NCT01288547

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: theobromine
Description: 700 mg theobromine in gelatin capsules given one time only

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Caffeine
Description: 120 mg caffeine in capsules given one time only

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: caffeine + theobromine
Description: 120 mg caffeine and 700 mg theobromine in capsules given one time only

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: cellulose in capsules given one time only
Study: NCT03645109

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Vitamin D3
Description: Capsules with 5,000 IU of vitamin D3 once a day (one capsule)

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Capsules with placebo (talcum food grade)
Description: Capsules with placebo (talcum food grade)
Study: NCT03979599

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: ultra-sound guided transversus abdominis plan block
Description: comparing ultrasound guided transversus abdominis plan block using combination of magnisum sulphate and levobupivacaine versus levobupivacaine

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: ultra-sound guided transversus abdominis plan block
Description: comparing ultrasound guided transversus abdominis plan block using combination of magnisum sulphate and levobupivacaine versus levobupivacaine
Study: NCT03965234

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Metastasectomy
Description: Undergo metastasectomy
Study: NCT01876056

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Brief CaCBTp
Description: Brief CBT for psychosis is comonly used in the West and had an established evidence base. Recently this therapy has been culturally adapted for use with clients from Pakistan.
Study: NCT01492660

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: echogenic needle and catheter
Description: Visibility of needle shaft and tip with engraved markers. Ultrasonographic Visibility of catheter tip

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Neurostimulation to position needle and catheter
Description: The non echogenic needle will be positioned using ultrasonography and neurostimulation and the catheter will be positioned using neurostimulation with plantar or dorsiflexion with 0.6-1.5mA current. 20mL of 2% mepivacaine will be injected via the catheter. Sensory motor block will be evaluated every 5 minutes for 30 mins
Study: NCT02424708

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Reduced Glutathione 100mg
Description: 100mg GSH delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Reduced Glutathione 200mg
Description: 200mg GSH delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Saline delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
Study: NCT00002625

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: topotecan hydrochloride

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: low-LET electron therapy

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: low-LET photon therapy
Study: NCT01927276

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Gluten Free Flour
Study: NCT02586155

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Atorvastatin
Description: High-Intensity Statin

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rosuvastatin
Description: High-Intensity Statin
Study: NCT00951665

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pertuzumab [Perjeta]
Description: Intravenous repeating dose
Study: NCT02586155

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rosuvastatin
Description: High-Intensity Statin
Study: NCT02234076

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: VRET
Study: NCT03979599

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: magnesium sulphate& levobupivacaine
Description: magnesium sulphate\& levobupivacaine
Study: NCT02369328

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: MULTIMODAL MRI
Description: Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months and neurological clinical exam , rankin score, NIHSS

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: MULTIMODAL MRI
Description: Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months and neurological clinical exam , rankin score, NIHSS
Study: NCT02234076

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: TAU
Description: Treatment as usual offered by the participating mental health care organisations
Study: NCT01958138

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: comparison of group-I (low dose propofol with isoflurane)
Description: Prior to LMA removal in group-I, isoflurane MAC awake (MAC less than 0.5) will be achieved in expiratory gases with 60% nitrous oxide and 40% oxygen. Propofol 1 mg/Kg will be combined with Isoflurane MAC awake and LMA will be removed after 20 seconds of propofol administration in group-I. The group-II LMA will be removed at end expiratory isoflurane MAC of 1.2% with 60% nitrous oxide and 40% oxygen
Study: NCT01927276

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Wheat Flour
Study: NCT01958138

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: comparison of group-I (low dose propofol with isoflurane)
Description: Prior to LMA removal in group-I, isoflurane MAC awake (MAC less than 0.5) will be achieved in expiratory gases with 60% nitrous oxide and 40% oxygen. Propofol 1 mg/Kg will be combined with Isoflurane MAC awake and LMA will be removed after 20 seconds of propofol administration in group-I. The group-II LMA will be removed at end expiratory isoflurane MAC of 1.2% with 60% nitrous oxide and 40% oxygen
Study: NCT01159561

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Western Equine Encephalitis Vaccine
Description: Subject will be vaccinated with 0.5 mL of reconstituted WEE vaccine, inactivated, TSI-GSD 210 (Lot 3-1-92) subcutaneously in the upper outer aspect of the deltoid region.
Study: NCT04118023

Intervention type: DIAGNOSTIC_TEST
Intervention: 7 Tesla Magnetic Resonance Imaging Test
Description: MAGNETOM Terra - 7T MRI Scanner by Siemens Healthineers. Each patient enrolled will undergo the study imaging test prior to planned diagnostic knee arthroscopy.
Study: NCT00378573

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: docetaxel

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gemcitabine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bevacizumab
Study: NCT00247962

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: etanercept
Description: 50 mg

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: sulphasalazine (SSZ)
Description: Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. Is achieved by the start of study week 5 of the study.