TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03088046

Intervention type: DRUG
Group type: OTHER
Intervention: Micronized Progesterone
Description: Anovulatory women with Polycystic ovary syndrome and clinical hyperandrogenism attended in our Hospital will participate in the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will participate in the trial. All patient information will be confidential and only be available to researches involved in the study.~Blood samples will be collected at baseline (Sample #1) and between the 3rd and the 5th day of withdrawal after 7 days of 100mg vaginal MP every 12 hours of administration(Sample#2).
Study: NCT02419014

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Active CES Device Alpha-Stim®
Description: The Alpha-Stim® device is a Class II FDA-approved device for the delivery of cranial electrotherapy using microcurrents that are delivered via two electrodes worn on the earlobes. Active CES devices will be pre-programmed by the manufacturer to deliver a bipolar, asymmetric rectangular waveform at a current of 100 µa, a level that is generally undetectable by the wearer of the device. At these settings, the manufacturer recommends a treatment duration of 60 minutes. Participants will not be able to alter the settings in any way.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Sham Device
Description: The inactive (sham) devices look identical to the active device but are inactivated by the manufacturer so as not to deliver any electrical current.
Study: NCT03201770

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: pyronaridine artesunate
Description: Antimalarial treatment
Study: NCT03156842

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fimasartan/Amlodipine, Rosuvastatin
Description: A fixed dose combination tablet of Fimasartan and Amlodipine and Rosuvastatin will be administrated once daily on treatment period.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fimasartan/Amlodipine
Description: A fixed dose combination tablet of Fimasartan and Amlodipine will be administrated once daily on treatment period.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fimasartan, Rosuvastatin
Description: Fimasartan and Rosuvastatin will be administrated once daily on treatment period.
Study: NCT02590575

Intervention type: DEVICE
Group type: OTHER
Intervention: Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform
Description: 1. With ongoing continuous hemofiltration and mechanical ventilation additional membrane gas exchange device (Prismalung®) in the renal replacement circulation; measurements of the effects on PaCO2 under varying blood and sweep gas flows~2. Afterwards, reduction of the tidal volume (VT) / plateau pressure until reaching the initial PaCO2value
Study: NCT00737347

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Lifestyle modification
Description: lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Lifestyle modification
Description: lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling
Study: NCT00990392

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Polysporin Triple Therapy ointment
Description: Polysporin Triple Therapy ointment applied to the insertion point at the time of CVC placement and twice within the first week.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Petroleum Jelly
Description: Petroleum jelly applied to the insertion point at the time of CVC placement and twice within the first week.
Study: NCT04737798

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: oil pulling with coconut oil
Description: using oil pulling therapy with coconut oil

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: oil pulling with sesame oil
Description: using oil pulling therapy with sesame oil
Study: NCT03403296

Intervention type: GENETIC
Intervention: nProfiler I Stomach Cancer Assay Kit
Description: qPCR by nProfiler I Stomach Cancer Assay Kit
Study: NCT00276991

Intervention type: DRUG
Group type: OTHER
Intervention: Kallunk oxide (Immunotherapy) 
Description: The study was assigned only one Arm \>450 cu/mm\^3 of baseline CD + T cells. HIV type-1 subjects were received one drug, a daily regimen of Kallunk oxide(Immunotherapy) + Long Pepper, that is a combination of a traditional alternative medicine(Complementary and Alternative Medicine CAM) as Kallunk oxide and appropriate drug carrier antidote. The drug assigns to 0.100 mg and 0.200 mg Kallunk oxide molecules with 199.900 mg, and 499.800 mg Antidote( This antidote was used as a carrier of Kallunk oxide molecules), respectively, for children and adults. Dosage: 200 mg for children and 500 mg for adults. This powder form sample size product was administered once daily dose on 5 days treatment. The Botanical name of the antidote is Piper Longum.
Study: NCT03743324

Intervention type: PROCEDURE
Intervention: Immediate Breast reconstruction
Description: Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer

Intervention type: PROCEDURE
Intervention: Immediate Breast reconstruction
Description: Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer

Intervention type: PROCEDURE
Intervention: Delayed Breast Reconstruction
Description: Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer

Intervention type: PROCEDURE
Intervention: Delayed Breast Reconstruction
Description: Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer

Intervention type: RADIATION
Intervention: Radiation
Description: Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy

Intervention type: RADIATION
Intervention: Radiation
Description: Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy
Study: NCT01576445

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Mid-vastus approach
Description: Mid-vastus approach to avoid patellar eversion and to minimise the muscle split.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: medial parapatellar approach
Description: medial parapatellar approach
Study: NCT01927549

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Immediate multivessel PCI

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Culprit Lesion only PCI
Study: NCT03826628

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rapamycin
Description: Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rapamycin
Description: Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks
Study: NCT00750139

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NAFT-500
Description: topical cream 1 application every day up to 4 weeks weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo 2-weeks
Description: placebo cream 1 application every day for up to 4 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Naftin 1%
Description: topical allylamine cream applied once a day for up to 4 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo 4-weeks
Description: topical placebo cream applied once a day for up to 4 weeks
Study: NCT03093649

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire
Description: The intervention was administrated through APP

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire
Description: patients receive normal care and visit
Study: NCT01865201

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Edaravone
Description: Be used at a dose of 30mg, intravenously, twice per day, for 14 days.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Common fundamental management
Description: common fundamental management, which was as follows: ①Methylprednisolone, administered by intravenous infusion at a 500mg daily for 3 consecutive days and then gradually tailed off in 30 days with administration of oral prednisolone. ②Dehydration drugs.
Study: NCT02659917

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: -Glass ionomer cement-
Description: Atraumatic Restorative Treatment
Study: NCT02836158

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: R-IDARAM plus intrathecal chemotherapy
Description: R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2); methotrexate 1.5 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 20mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.
Study: NCT01896635

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: FMT infusions
Description: Active FMT derived from healthy anonymous pre-screened donors

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo infusion
Description: Placebo infusion not containing any donor microbial material
Study: NCT03432884

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BGB-3111
Description: Subjects will receive BGB-3111

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BGB-3111
Description: Subjects will receive BGB-3111

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects will receive Placebo
Study: NCT03409432

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Brentuximab Vedotin
Description: Given IV

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide
Description: Given PO
Study: NCT02068781

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Low-sodium diet
Description: 50 mmol NaCl per 24h

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Low-sodium diet
Description: 50 mmol NaCl per 24h

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: High-sodium diet
Description: 250 mmol NaCl per 24h
Study: NCT03432884

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Subjects will receive Placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Moxifloxacin
Description: Subjects will receive Moxifloxicin
Study: NCT01101360

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Matrix RF
Description: Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Matrix RF followed by Pulse Dye Laser
Description: Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Pulse Dye Laser followed by Matrix RF
Description: Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
Study: NCT03629860

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Atrophic maxillary alveolar ridge augmentation
Description: Autogenous bone blocks from chin and ascending ramus are obtained and used for reconstruction of atrophic maxillary ridges

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Atrophic maxillary alveolar ridge augmentation
Description: Autogenous bone blocks from chin and ascending ramus are obtained and used for reconstruction of atrophic maxillary ridges
Study: NCT02875275

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Glucose with grass jelly solution
Description: 50 g glucose and 3.12 g grass jelly dissolve in water (top up to 200g)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Glucose with grass jelly (solid)
Description: 50 g glucose and 3.12 g grass jelly and 3.12g starch dissolve in hot water (top up to 200g)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Porridge and juice with coconut oil
Description: Add instant porridge with hot water with oil. Consume with commercially available orange juice

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Porridge and juice with coconut oil gel
Description: Add instant porridge with hot water with oleogel. Consume with commercially available orange juice
Study: NCT05680961

Intervention type: DEVICE
Intervention: Monitoring Device
Description: Monitoring Device
Study: NCT04122391

Intervention type: OTHER
Intervention: sound level volume
Description: Noise level during cardiac arrest

Intervention type: OTHER
Intervention: sound level volume
Description: Noise level during cardiac arrest
Study: NCT02889601

Intervention type: OTHER
Intervention: Psycho-behavioural assessment
Description: DAPHNE Scale

Intervention type: OTHER
Intervention: Psycho-behavioural assessment
Description: DAPHNE Scale
Study: NCT03254160

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DNS-3379
Description: DNS-3379

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DNS-3379
Description: DNS-3379

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo
Study: NCT04701528

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Voclosporin
Description: Temporarily switching of tacrolimus maintenance immunosuppression to voclosporin maintenance immunosuppression with possible additional anti-viral activity
Study: NCT02178410

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Vitamin D3
Description: Vitamin D3 (cholecalciferol), 2000 IU per day.

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Vitamin D3
Description: Vitamin D3 (cholecalciferol), 2000 IU per day.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Omega-3 fatty acids (fish oil)
Description: Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Study: NCT04701528

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tacrolimus
Description: Comparator
Study: NCT02178410

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Omega-3 fatty acids (fish oil)
Description: Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Fish oil placebo
Description: Fish oil placebo

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Fish oil placebo
Description: Fish oil placebo

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Vitamin D3 placebo
Description: Vitamin D3 placebo

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Vitamin D3 placebo
Description: Vitamin D3 placebo
Study: NCT03480217

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Multifaceted Implementation Strategy
Description: Key components include:~* educational presentations to primary care providers at grand rounds~* patient information materials on ABPM and HBPM~* training registered nurses to assist providers with teaching patients to conduct HBPM~* information on how to order ABPM and HBPM to clinicians, nurses and front desk staff via huddles, emails, and other electronic communications~* a computerized EHR-embedded clinical decision support tool that prompts providers to recall the USPSTF hypertension guidelines and facilitates ordering of HBPM and ABPM for guideline-eligible patients~* periodic feedback to primary care providers about clinic-level success with appropriately ordering ABPM and HBPM for eligible patients~* an accessible, culturally-adapted and locally tailored ABPM service
Study: NCT02112760

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: specific stabilization exercise
Description: The specific stabilization exercise refers to an exercise that targets the deep trunk muscle, including the multifidus and transversus abdominis with ultrasound feedback.
Study: NCT02653573

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Coaching
Description: Self-management education
Study: NCT00594191

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Simvastatin
Description: 20 mg/day p.o., increased to 40 mg/day at day 15 if no safety end-point was met

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo with the same characteristics of the drug and at the same dose
Study: NCT01422369

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pitavastatin (NK-104)
Description: Pitavastatin (NK-104) 4mg once daily (QD)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Darunavir/Ritonavir (Prezista)
Description: Darunavir/Ritonavir (Prezista) 800 mg/100 mg
Study: NCT01028261

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: ZGN-433
Description: Subjects will receive placebo or ZGN-433 twice weekly over 6 weeks treatment period for a total of 12 doses. A range of doses will be evaluated.
Study: NCT01685125

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: abiraterone acetate
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: abiraterone acetate
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dasatinib
Description: Given PO

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: prednisone
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: prednisone
Description: Given PO
Study: NCT00280709

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Nitinella ; SX-ELLA Stent Biliary (biliary metal stent)
Description: Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Nitinella ; SX-ELLA Stent Biliary (biliary metal stent)
Description: Nitinella covered (arm 1) or uncovered (arm 2) biliary metal stent. Maximum diameter 10 mm, length 52 or 72 mm
Study: NCT03441919

Intervention type: RADIATION
Intervention: PET-CT (positron emission tomography - computer tomography)
Description: PET-CT to determine vascular inflammation

Intervention type: RADIATION
Intervention: PET-CT (positron emission tomography - computer tomography)
Description: PET-CT to determine vascular inflammation

Intervention type: RADIATION
Intervention: PET-CT (positron emission tomography - computer tomography)
Description: PET-CT to determine vascular inflammation
Study: NCT02068781

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: High-sodium diet
Description: 250 mmol NaCl per 24h
Study: NCT03441919

Intervention type: DIAGNOSTIC_TEST
Intervention: Blood drawn
Description: Blood drawn

Intervention type: DIAGNOSTIC_TEST
Intervention: Blood drawn
Description: Blood drawn

Intervention type: DIAGNOSTIC_TEST
Intervention: Blood drawn
Description: Blood drawn
Study: NCT00888394

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: chiropody
Description: basic procedure of chiropody in podiatry

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: basic orthesis
Description: individual basic orthesis of foot

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: advantage orthesis
Description: advantage orthesis of foot with special material and design

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: chiropody and advantage orthesis
Description: chiropody and advantage orthesis of foot
Study: NCT02231814

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Crohns Disease Exclusion Diet + PEN
Description: Patients will use the CDED for a 24 week period, coupled with 1000 ml of polymeric formula (1 Kcal/mL) for the first 6 weeks. For weeks 7 to 24 patients will use the CDED coupled with 600 ml formula and a calcium supplement. The CDED is divided into 3 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Crohns Disease Exclusion Diet
Description: Crohn's Disease Exclusion Diet alone with a calcium supplement during the study (0-24). The CDED is divided into 3 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase.
Study: NCT04494243

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AD-214 10/600mg
Description: 1 tablet administered before the breakfast during 7 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AD-214 10/600mg
Description: 1 tablet administered before the breakfast during 7 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rabeprazole 10mg
Description: 1 tablet administered before the breakfast during 7 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rabeprazole 10mg
Description: 1 tablet administered before the breakfast during 7 days
Study: NCT03403556

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rosuvamibe
Description: Rosuvastatin 10mg/Ezetimibe10mg qd for 24 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Monorova
Description: Rosuvastatin 20mg qd for 24 weeks
Study: NCT00993018

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-42160443 (1 mg)
Description: JNJ-42160443 1 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-42160443 (3 mg)
Description: JNJ-42160443 3 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-42160443 (10 mg)
Description: JNJ-42160443 10 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Patients will receive single injection of matching placebo every 28 days for up to 52 weeks.