AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT03743441 — intervention group
Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Exercise therapy
Description: Concentric and eccentric exercises with a total duration of approximately 20 minutes.
Study NCT03743441 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Cryotherapy
Description: Twenty minutes of cryotherapy applied to the Achilles tendon.
Study NCT03743441 — intervention group
Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Cryotherapy
Description: Twenty minutes of cryotherapy applied to the Achilles tendon.
Study NCT02568735 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexketoprofen
Description: After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
Study NCT02568735 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoricoxib
Description: After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
Study NCT01602224 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Administered IV
Study NCT01602224 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Administered orally
Study NCT01602224 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Dexamethasone
Description: Administered orally
Study NCT01602224 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bortezomib
Description: Administered SQ
Study NCT01602224 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Bortezomib
Description: Administered SQ
Study NCT01602224 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Tabalumab
Description: Administered IV
Study NCT04575194 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Liraglutide 6 MG/ML [Saxenda]
Description: 3 mg of sc liraglutide daily plus lifestyle intervention
Study NCT04575194 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Naltrexone-Bupropion Combination
Description: 32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention
Study NCT03063463 — intervention group
Intervention type: PROCEDURE
Intervention: pneumatic dilation
Description: Pneumatic dilation of the lower esophageal sphincter (LES) consists of inserting a guide wire under visual control into the stomach and to pass the balloon over the guide wire. The balloon is inflated, disrupting the muscle fibers of the sphincter.
Study NCT03063463 — intervention group
Intervention type: PROCEDURE
Intervention: surgical myotomy
Description: This procedure destroys the muscles at the gastroesophageal junction, allowing the valve (LES) between the esophagus and stomach to remain open.
Study NCT02996344 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Didactic training
Description: Six online training modules pertaining to suicide prevention in primary care.
Study NCT02996344 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Didactic training
Description: Six online training modules pertaining to suicide prevention in primary care.
Study NCT02996344 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Standardized patient interaction
Description: Two standardized patient practice interactions - 1 face-to-face, 1 remote/telehealth.
Study NCT00774761 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: fluticasone propionate/formoterol fumarate
Description: inhalation suspension
Study NCT00774761 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: fluticasone propionate
Description: inhalation suspension
Study NCT00774761 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: formoterol fumarate
Description: inhalation solution
Study NCT01725906 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: empirical therapy
Description: 1. Nexium (esomeprazole), 40mg, bid, 14 days, plus~2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus~3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs~4. Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14
Study NCT01725906 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Genotypic resistance guided therapy
Description: 1. Nexium (esomeprazole), 40mg, bid, 14 days, plus~2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus~3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs~4. Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14
Study NCT02217839 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DG3173
Study NCT02217839 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DG3173+Octreotide
Study NCT02217839 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Octreotide
Study NCT02217839 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DG3173 Placebo
Study NCT02217839 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DG3173 Placebo+Octreotide Placebo
Study NCT02217839 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Octreotide+DG3173 Placebo
Study NCT03074409 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: oxytocin
Description: self-administration of oxytocin (nasal spray)
Study NCT03074409 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: self-administration of placebo (nasal spray)
Study NCT02772601 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Caffeine
Study NCT02772601 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Warfarin
Study NCT02772601 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Omeprazole
Study NCT02772601 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metoprolol
Study NCT02772601 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Midazolam
Study NCT02772601 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Risankizumab
Study NCT01723098 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise group
Description: Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training~Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.
Study NCT03058120 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Deferral of admission for stress test
Description: Early discharge; admission and stress test are deferred.
Study NCT04862715 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ferinject
Description: Active study medication Medication name: Ferinject® Active ingredient: Ferric carboxymaltose Dosage form: 50 mg iron/ml solution for injection/infusion. Appearance: Dark brown, non-transparent aqueous solution Excipients: Sodium hydroxide, hydrochloric acid and water for injection Strength/Packaging: Each 2 ml vial contains 100 mg of iron as ferric carboxymaltose.~Each 10 ml vial contains 500 mg of iron as ferric carboxymaltose. Each 20 ml vial contains 1,000 mg of iron as ferric carboxymaltose. Manufacturer: Vifor Pharma UK Limited
Study NCT04862715 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo: NaCl (sodium chloride 0.9%)
Description: Medication name: NaCl (sodium chloride 0.9%) Active ingredient: NaCl (sodium chloride 0.9%) Dosage form: 0.9% w/v NaCl as sterile solution in water for injection Excipients: Water Strength/Packaging: 100 ml container with 100 ml normal saline Manufacturer: As per local hospital supplier
Study NCT01319669 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: recombinant human thrombopoietin
Description: Recombinant human thrombopoietin injection in 15000U/ml/amp.
Study NCT01319669 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: recombinant human thrombopoietin
Description: Recombinant human thrombopoietin injection in 15000U/ml/amp.
Study NCT00823862 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SD-101
Description: Intramuscular (IM)
Study NCT00823862 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ribavirin
Description: oral, 2 times per day, for 2 months
Study NCT04027855 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: collection of peripheral blood mononuclear cells from healthy volunteers
Description: 1. Screening period: All volunteers are required to sign a written informed consent form for the study; after the signing of informed consent form, the demographic data and medical history of the volunteers will be collected, and physical examinations and local laboratory tests will be performed to assess the eligibility of the volunteers. Volunteers who meet all the inclusion criteria and do not meet any exclusion criteria (except for the basic biological indicators of UCAR-T product preparation) will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled.~2. Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis.
Study NCT02021201 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: risperidone
Description: Patients with schizophrenia will be treated for 10 weeks treatment with risperidone
Study NCT02021201 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sertindole
Description: Patients with schizophrenia will be treated for 10 weeks treatment with serindole
Study NCT04471519 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: BBV152A - Phase I
Description: 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
Study NCT04471519 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: BBV152B - Phase I
Description: 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
Study NCT04471519 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: BBV152C - Phase I
Description: 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
Study NCT04471519 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Placebo - Phase I
Description: 0.5 ml of the Placebo will be administered intramuscularly twice at Day 0 and Day 14
Study NCT04471519 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: BBV152A - Phase II
Description: 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28
Study NCT04471519 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: BBV152B - Phase II
Description: 0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28
Study NCT03057093 — intervention group
Intervention type: OTHER
Intervention: Non interventional study
Description: retrospective noninterventional study
Study NCT00837252 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Finasteride
Description: Participants received 5mg of oral finasteride daily for three months.
Study NCT04239001 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEG-rhG-CSF
Description: 24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, patients with pancreatic cancer who met the input / discharge criteria were given secondary prophylactic administration of the tested drug PEG-rhG-CSF.
Study NCT03741088 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: VORTX Rx treatment
Description: Cavitation-based cellular destruction using focused ultrasound
Study NCT01908426 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cabozantinib tablets
Study NCT01908426 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo tablets
Study NCT04445935 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bivalirudin Injection
Description: The patients will receive iv Bivalirudin according to the institutional HIT protocol.
Study NCT04445935 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Standard treatment
Description: This group will receive standard anticoagulation with LMWH/UFH
Study NCT01853826 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: afatinib
Description: Patients will receive afatinib once daily
Study NCT00262860 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bortezomib
Study NCT00262860 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: gemcitabine hydrochloride
Study NCT02741128 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CYD Dengue Vaccine
Description: 0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
Study NCT02741128 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (NaCl 0.9%) vaccine group
Description: 0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
Study NCT04406298 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: small quantity paracentesis
Description: Intermittent small quantity paracentesis (upto 3L/day) for upto 5 days
Study NCT04406298 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Large Volume Paracentesis
Description: Large Volume Paracentesis > 5litres
Study NCT01102686 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pyrimethamine
Description: Pyrimethamine will be taken orally as a single daily dose of 25 mg/day for 4 weeks, then increasing by 25 mg per dose in three four-week steps, to a final dose of 100 mg/day
Study NCT01102686 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin
Description: To eliminate or minimize potential hematologic effects of Pyrimethamine, Leucovorin is to be co-administered with Pyrimethamine at a dose level of 5 mg per day, given when Pyrimethamine is administered.
Study NCT02743585 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Filmarray Blood Culture ID (BCID) panel
Description: The BCID panel is an FDA-approved nucleic acid amplification test (based on nested polymerase chain reaction) which detects Gram positive, Gram negative, the major Candida species and antimicrobial resistance markers (mecA for methicillin resistance, van A/B for vancomycin resistance, blaKPC for KPC carbapenemase) directly from positive blood cultures in \< 1 - 1.5 hours
Study NCT02743585 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Rosco Diagnostica ESBL/carbapenemase screen kit
Description: These kits are CE-marked (Approved in the European Union) rapid chromogenic tests for extended-spectrum beta-lactamase / carbapenemase detection from both blood cultures and cultured bacterial colonies.
Study NCT03658421 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine
Description: Dexmedetomidine added to lower concentration of ropivacaine for postoperative analgesia in FNB
Study NCT03658421 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: ultrasound-guided femoral nerve block
Description: ultrasound-guided femoral nerve block, a single bolous of 20 ml ropivacaine (concentration 0.2% for H group or 0.1% for L group) before surgery followed by continuous femoral nerve block using an infusion rate of ropivacaine 0.2% 5 ml/h for postoperative analgesia started right after surgery
Study NCT03658421 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: intravenous patient-controlled analgesia pump with morphine
Description: All subjects received intravenous patient-controlled analgesia (IV-PCA) pumps to measure additional morphine consumption, which included 50 mg morphine in 50 ml saline: bolus 2 mg; lock out time, 15 minutes.
Study NCT03658421 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Continuous femoral nerve block
Description: All the continuous femoral nerve block infusion regimes in the pump were connected to CFNB catheter, which contained only ropivacaine with different concentrations (ropivacaine 0.1% for L group and LD group; ropivacaine 0.2% for H group, 5 ml/h).
Study NCT04614311 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Triamcinolone Hexacetonide 20 MG/ML
Description: JIA patients (age 1-18 years) starting TNFi treatment randomised to intervention will receive treatment with intra articular glucocorticoids (triamcinolone hexacetonide) injections in inflamed joints
Study NCT04085575 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Acide Tranexamique
Description: Recruited patients were randomly before the operation by generating random numbers with Microsoft Excel 2007. They were assigned in two groups: 1 g of intra-articular tranexamic acid (TXA) and 2 g of intra-articular tranexamic acid.
Study NCT04426929 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Conventional exercise therapy
Description: Coldpack, TENS, Ultrasound agents and conventional exercise therapy (codman, wand, isometric exercise) will be applied.
Study NCT04426929 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Closed Chain Exercise Group
Description: An exercise program consisting of 3 phases that runs from simple to difficult and includes closed kinetic chain exercises and proprioceptive exercises will be implemented in this group.
Study NCT04426929 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Video Based Exercise Group
Description: Closed chain exercises based on video games will be applied. These exercises also include proprioceptive exercises.
Study NCT01017484 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: DASH, Control
Description: controlled feeding of either the DASH dietary pattern or a typical American diet at isocaloric level.
Study NCT04149912 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Online questionnaire
Description: Online questionnaire via SoSciSurvey
Study NCT00699036 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: avandia
Description: 4 mg twice daily
Study NCT00699036 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: metformin
Description: 500 mg twice daily for 48 weeks
Study NCT00699036 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: losartan
Description: losartan 50 mg once daily
Study NCT03977792 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BOR15001L7
Description: BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection.
Study NCT03977792 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Docosanol Cream 10%
Description: Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection.
Study NCT02161770 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: AZD9291 tablet dosing
Description: Part A - single 80mg oral dose AZD9291 (administered as 1 80mg tablet). Part B - 80mg oral dose AZD9291 od.
Study NCT02161770 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Pharmacokinetic sampling - AZD9291
Description: Blood sampling to measure AZD9291 pharmacokinetic parameters.
Study NCT02161770 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: Pharmacokinetic sampling - AZ5140 and AZ7550
Description: Blood samples to measure the pharmacokinetic parameters of AZ5104 and AZ7550.
Study NCT01405768 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: sodium bicarbonate buffered lidocaine
Description: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.
Study NCT01405768 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Non-buffered lidocaine
Study NCT00265564 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Modified Seeking Safety integrated into std outpatient SUD care
Description: The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks.
Study NCT00265564 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Standard outpatient SUD care
Description: Patients assigned to standard care meet twice weekly in Recovery 1 groups, which focuses on building abstinence.
Study NCT04823403 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab
Description: Intravenous Nivolumab (1mg/kg) will be given every 6 weeks for a maximal period of 6 months within the study.
Study NCT04823403 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ipilimumab
Description: Ipilimumab, single intra-arterial (IA) injection per patient, at 3 dose-levels\*.~* (D1) Starting dose : 50 mg; n=3 to 6~* (D2) 2nd dose-level : 100 mg; n=3 to 6~* (D3) Maximal tested dose : 150mg; n=3 to 6 (if no limiting toxicities) \*Dose level (D-1) : 25 mg will be tested if de-escalation is needed at D1 (>1/3 DLT at D1)
Study NCT04175249 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pizza meal challenge
Description: Vegetarian pizza containing 10 grams of salt
Study NCT01557153 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amlodipine
Description: Starting dose will be 5mg/day for four weeks. All participants will be titrated up to the maximum of 10mg/day after 4 weeks. If they do not tolerate this dose, it will be reduced again to 5mg/day and they will continue on their maximum tolerated dose for 12 weeks (for a total of 16 weeks of medication or placebo)