TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02072668

Intervention type: DRUG
Group type: OTHER
Intervention: rivaroxaban
Description: Subject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form OR Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form.

Intervention type: DRUG
Group type: OTHER
Intervention: rivaroxaban
Description: Subject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form OR Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form.

Intervention type: DRUG
Group type: OTHER
Intervention: placebo
Description: Subject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form OR Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form.

Intervention type: DRUG
Group type: OTHER
Intervention: placebo
Description: Subject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form OR Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form.
Study: NCT01164514

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CPG 7909
Description: CPG 7909 is a synthetic oligodeoxynucleotide used as an adjuvant and administered at 2 different dosages: 250 mcg and 500 mcg.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CPG 7909
Description: CPG 7909 is a synthetic oligodeoxynucleotide used as an adjuvant and administered at 2 different dosages: 250 mcg and 500 mcg.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: J5-OMP Vaccine
Description: J5-OMP vaccine 10 mcg to be administered with and without CpG 7909 adjuvant 250 or 500 mcg, intramuscularly on Days 0, 29 and 59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: J5-OMP Vaccine
Description: J5-OMP vaccine 10 mcg to be administered with and without CpG 7909 adjuvant 250 or 500 mcg, intramuscularly on Days 0, 29 and 59.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: J5-OMP Vaccine
Description: J5-OMP vaccine 10 mcg to be administered with and without CpG 7909 adjuvant 250 or 500 mcg, intramuscularly on Days 0, 29 and 59.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Normal saline.
Study: NCT03238378

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Brachytherapy
Description: Brachytherapy d 1-5(6)

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Hyperthermia
Description: Hyperthermia d 2 + 5
Study: NCT02512822

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Noninvasive Radiofrequency TruSculpt
Description: Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.
Study: NCT01542047

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin
Description: Carboplatin will be administered intravenously over approximately 30 minutes on day 1 of each cycle. The dosage used will be 5 AUC for the first 5 cycles, and will be increased to 6 AUC for the sixth cycle.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pazopanib
Description: Pazopanib will be administered orally at 200 to 800 mg/kg2. It will be given either on days 1 through 21 of each 3-week cycle, or if needed, it will be given on days 3 through 19.
Study: NCT00284947

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: basiliximab
Description: 40 mg once every 28 days intravenously for 24 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MMF/EC-MPS
Description: 1g MMF or 720mg EC-MPS p.o twice daily

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Corticosteroids
Description: Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days
Study: NCT03264326

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Blood Flow Restriction Training
Description: Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise.

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Sham Blood Flow Restriction Training
Description: Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Eccentric Exercise
Description: Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Eccentric Exercise
Description: Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.
Study: NCT00628420

Intervention type: DRUG
Group type: OTHER
Intervention: ACP-104
Description: 25mg, 75mg, 125mg, 175mg, 225mg, or 275mg once a day for 2 weeks

Intervention type: DRUG
Group type: OTHER
Intervention: ACP-104
Description: Patient will be given either 50mg, 100mg, 150mg, 200mg, 250mg, or 300mg daily for 2 weeks

Intervention type: DRUG
Group type: OTHER
Intervention: Placebo
Description: patients will be given a placebo: 25mg, 50mg, 75mg, 100mg, 125mg, 150mg, 175mg, 200mg, 225mg, 250mg, 275mg, or 300mg (to match the doses given) daily for 2 weeks.
Study: NCT03350594

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Systemic Family Therapy
Description: Patient will have 10 sessions of Systemic Family Therapy during 12 months with his/her family.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Multiple Family Therapy
Description: Patient and his/fer family will have 10 sessions of Multiple Family Therapy during 12 months.
Study: NCT00570986

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: ABT-874
Description: 200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: ABT-874
Description: 100mg every 12 weeks.
Study: NCT03798951

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Prehabilitation
Description: The patients included in the treatment group will follow a prehabilitation program, based on a physiotherapist, nutritionist and psychologist evaluation. All the treatments will be tailored according the characteristics of each single patient.~The program will have a duration of, at least, 4 weeks.
Study: NCT04470154

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Stage I:HSK21542 0.05 μg/kg
Description: Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Stage I:HSK21542 0.15 μg/kg
Description: Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Stage I:HSK21542 0.30 μg/kg
Description: Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Stage I:HSK21542 0.80 μg/kg
Description: Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Stage II:HSK21542 0.3 μg/kg
Description: Randomized to HSK21542 0.3 μg/kg or 0.6 μg/kg or the corresponding placebo group

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Stage II:HSK21542 0.6 μg/kg
Description: Randomized to HSK21542 0.3 μg/kg or 0.6 μg/kg or the corresponding placebo group
Study: NCT03410706

Intervention type: DRUG
Intervention: Rivaroxaban(Xarelto, BAY 59-7939)
Description: The dosage and the anticoagulation duration is decided by investigators. As list in product information, the PE treatment dosage of rivaroxaban is 15mg bid for first 21 days and then 20mg qd. If CrCl is 30-49 ml/min and bleeding risk is over VTE recurrence risk, 20mg qd can be replaced with 15mg qd.
Study: NCT01955135

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ketamine
Description: 1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sevoflurane
Description: anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: propofol
Description: 1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol
Study: NCT04278599

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oral Zinc supplementation
Description: In the test group, the patients will be administered Zinc Acetate tablets (equivalent to 30 mg of elemental zinc/day) for 6 weeks from the baseline. They will also be will be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Oral placebo supplementation
Description: In the control group, the patients will be administered Placebo tablets for 6 weeks from the baseline. They will also be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months.
Study: NCT01456884

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Live guitar and vocal music therapy
Description: Live guitar and vocal music therapy. Subject is passive recipient for 30 minutes.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Live guitar and vocal music therapy
Description: Live guitar and vocal music therapy. Subject is passive recipient for 30 minutes.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Vibroacoustic Music Therapy
Description: 30 minutes using vibroacoustic mat.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Vibroacoustic Music Therapy
Description: 30 minutes using vibroacoustic mat.
Study: NCT04032964

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: L19TNF
Description: L19TNF 13 µg/kg i.v. will be administered on day 1, 3 and 5 of each 21-day cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DOXORUBICIN
Description: Doxorubicin 75 mg/m2 will be administered on day 1 of each 21-day cycle
Study: NCT04322526

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Naltrexone 50 Mg Oral Tablet
Description: Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015) (onset of action: ≥15 minutes; peak effect: \~1 hour; duration: \~24 hours).

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Naltrexone 50 Mg Oral Tablet
Description: Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015) (onset of action: ≥15 minutes; peak effect: \~1 hour; duration: \~24 hours).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo oral tablet
Description: Placebo tablet that has no inherent power to produce an effect. In the inert pill condition, participants will receive an oral placebo tablet.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo oral tablet
Description: Placebo tablet that has no inherent power to produce an effect. In the inert pill condition, participants will receive an oral placebo tablet.
Study: NCT03146585

Intervention type: DEVICE
Intervention: PBR assessment
Description: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.

Intervention type: DEVICE
Intervention: PBR assessment
Description: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.

Intervention type: DEVICE
Intervention: PBR assessment
Description: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
Study: NCT03814603

Intervention type: PROCEDURE
Intervention: PET-MR Scan
Description: Participants will undergo PET-MR scans at baseline and two-year follow up to examine brain amyloid deposition longitudinally.

Intervention type: PROCEDURE
Intervention: PET-MR Scan
Description: Participants will undergo PET-MR scans at baseline and two-year follow up to examine brain amyloid deposition longitudinally.

Intervention type: DRUG
Intervention: PiB
Description: Subjects will receive a single dose of 555 MBq of PiB and perform a dynamic 30 min PiB PET-MR scan 60 min after injection.

Intervention type: DRUG
Intervention: PiB
Description: Subjects will receive a single dose of 555 MBq of PiB and perform a dynamic 30 min PiB PET-MR scan 60 min after injection.
Study: NCT01850121

Intervention type: DRUG
Intervention: Infliximab
Description: 5 mg/kg every 6 weeks during the first year and 3 mg/kg every 8 weeks during the second year. Concomitant treatment with methotrexate 7.5 mg/week.
Study: NCT01457508

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: DTPa-HBV-IPV/Hib (Infanrix hexa™)
Description: Three doses administered intramuscularly

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: DTPa-HBV-IPV (Infanrix penta™)
Description: Three doses administered intramuscularly

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Hib (Hiberix™)
Description: Three doses administered intramuscularly
Study: NCT01873872

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Theralac probiotic

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Culturelle probiotic

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Study: NCT02667119

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Prolonged Exposure with Contingency Management
Description: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.~Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Standard Care
Description: Standard care will consist of treatment as usual in a community-based substance use treatment center.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Standard Care
Description: Standard care will consist of treatment as usual in a community-based substance use treatment center.
Study: NCT00549783

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Botulinum Toxin Type A 900kD
Description: The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness.~First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
Study: NCT01767090

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASP1707
Description: Oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASP1707
Description: Oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASP1707
Description: Oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASP1707
Description: Oral

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Oral

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Leuprorelin acetate
Description: subcutaneous
Study: NCT01071304

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Midazolam
Description: A single oral dose of midazolam 2 mg (1 mL of 2 mg/mL syrup) was given on Day -2 and Day 5.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ridaforolimus
Description: Ridaforolimus 40 mg (4 x 10 mg tablets) oral once daily on Days 1 through 5.
Study: NCT03200249

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Preoperative chemo-radiation with IG-IMRT dose escalation
Study: NCT00935584

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Physician training in patient-centered emr use
Description: This intervention was performed in between the pre-intervention (Baseline) clinic visit and post intervention clinic visit.
Study: NCT02689635

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Sodium Restricted Diet
Description: Cardiac Diet, as defined by our Hospital Nutritional Services (containing less than 2000 mg sodium per day)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Regular Diet
Description: Non-Cardiac Diet, as defined by our Hospital Nutritional Services
Study: NCT03230461

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Compression depth
Study: NCT00549783

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness.~First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
Study: NCT01775280

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Injection of Ytttrium-90 microspheres into the hepatic artery
Description: INjection of Y-90 particles into the hepatic artery using endovascular access
Study: NCT00521066

Intervention type: DEVICE
Intervention: GYNECARE PROSIMA* Pelvic Floor Repair System
Description: procedure for pelvic organ prolapse
Study: NCT02850120

Intervention type: PROCEDURE
Intervention: Tension-free vaginal tape (TVT)
Description: Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence.

Intervention type: PROCEDURE
Intervention: Tension-free vaginal tape (TVT)
Description: Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence.

Intervention type: PROCEDURE
Intervention: Trans-obturator tape (TOT)
Description: Surgical insertion of Trans-obturator tape (TOT) polypropylene mesh in the treatment of stress urinary incontinence.

Intervention type: PROCEDURE
Intervention: Trans-obturator tape (TOT)
Description: Surgical insertion of Trans-obturator tape (TOT) polypropylene mesh in the treatment of stress urinary incontinence.

Intervention type: PROCEDURE
Intervention: Suprapubic sling (SS)
Description: Surgical insertion of Suprapubic sling (SS) polypropylene mesh in the treatment of stress urinary incontinence.

Intervention type: PROCEDURE
Intervention: Suprapubic sling (SS)
Description: Surgical insertion of Suprapubic sling (SS) polypropylene mesh in the treatment of stress urinary incontinence.
Study: NCT02335710

Intervention type: DEVICE
Intervention: Journey II BCS TKA
Study: NCT02325557

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ADXS31-142
Description: ADXS31-142 IV infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ADXS31-142
Description: ADXS31-142 IV infusion

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pembrolizumab
Description: Pembrolizumab IV infusion
Study: NCT02936167

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Ringer Lactate
Study: NCT03230461

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Compression depth

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Compression depth
Study: NCT03846492

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Transcranial Direct Current Stimulation (tDCS)
Description: tDCS is a non-invasive brain stimulation modality that does not require general anesthesia or surgical implantation of a device. tDCS utilizes low intensity electrical current either to increase cortical excitability with an anodal electrode or to suppress cortical excitability with a cathodal electrode. It uses 3 AAA batteries to deliver direct current via rubber electrodes enclosed in saline soaked sponges.

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Transcranial Direct Current Stimulation (tDCS)
Description: tDCS is a non-invasive brain stimulation modality that does not require general anesthesia or surgical implantation of a device. tDCS utilizes low intensity electrical current either to increase cortical excitability with an anodal electrode or to suppress cortical excitability with a cathodal electrode. It uses 3 AAA batteries to deliver direct current via rubber electrodes enclosed in saline soaked sponges.
Study: NCT03038061

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Patients undergoing Laparoscopic Surgery
Description: Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery).
Study: NCT01484587

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CNTO 1959
Description: CNTO 1959: type=range, unit=mg, number=10, 30, 100, 300, form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo: form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks