TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03812445

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Probiotics
Description: the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus,Bifidobacterium lactobacillus,Lactobacillus paracasei,Lactobacillus rhamnosus and Lactobacillus fermentium with does of 8\*10\^9 Colony-Forming Units(CFU) \*2/d for 3 months.
Study: NCT00992017

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Influenza A (H1N1) monovalent vaccine
Description: Two 15-microgram intramuscular vaccine injections given together form one dose; two doses (four total injections) are given 21 days apart
Study: NCT02928523

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Autologous Fecal Microbiota Transplantation
Study: NCT03207997

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: unenhanced MR sequences
Description: 2 additional unenhanced MR sequences

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: unenhanced MR sequences
Description: 2 additional unenhanced MR sequences

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: unenhanced MR sequences
Description: 2 additional unenhanced MR sequences

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: unenhanced MR sequences
Description: 2 additional unenhanced MR sequences
Study: NCT04057378

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Electroconvulsive therapy
Description: Electrically induced convulsion under anesthesia

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Electroconvulsive therapy
Description: Electrically induced convulsion under anesthesia
Study: NCT03472612

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: CPAP withdrawal
Description: Short-term withdrawal of CPAP therapy in moderate to severe OSA
Study: NCT00697853

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Engerix™-B
Description: 3-dose intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HBV-MPL vaccine 208129
Description: 2-dose intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HBV-MPL vaccine 208129
Description: 2-dose intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HBV-MPL vaccine 208129
Description: 2-dose intramuscular injection

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HBV-MPL vaccine 208129
Description: 2-dose intramuscular injection
Study: NCT02487797

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxytocin

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxytocin

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Sodium Chloride 0.9%

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Sodium Chloride 0.9%
Study: NCT04298827

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Unimodal
Description: Patients will receive physical therapy alone.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Trimodal
Description: Patients will receive physical therapy, nutrition counseling, and cognitive behavioral therapy in the form of group counseling.
Study: NCT04540328

Intervention type: OTHER
Group type: OTHER
Intervention: Non-surgical periodontal treatment
Study: NCT04213092

Intervention type: PROCEDURE
Intervention: ERCP+LC
Description: Patients in this group underwent a single setting ERCP and Laparoscopic cholecystectomy.

Intervention type: PROCEDURE
Intervention: OC+CBD
Description: Patients in this group underwent a single setting open cholecystectomy and open CBD exploration.
Study: NCT03973541

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cognitive Behavioral Therapy with Exposure therapy
Description: Treatment will be conducted for 10 consecutive weekly 60 min sessions. In the first two treatment conditions sessions are scheduled as follows: Session one: Building a therapeutic alliance and psycho-education about social anxiety and safety and avoidance behaviors. Session two to four: Cognitive restructuring. Session five to nine: Exposure in either in vivo or VR. Session 10: Relapse prevention. Sessions one to four and ten are identical in the two of three treatment arms.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Cognitive Behavioral Therapy with Exposure therapy
Description: Treatment will be conducted for 10 consecutive weekly 60 min sessions. In the first two treatment conditions sessions are scheduled as follows: Session one: Building a therapeutic alliance and psycho-education about social anxiety and safety and avoidance behaviors. Session two to four: Cognitive restructuring. Session five to nine: Exposure in either in vivo or VR. Session 10: Relapse prevention. Sessions one to four and ten are identical in the two of three treatment arms.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Relaxation Therapy
Description: Relaxation Therapy
Study: NCT01689441

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Calcitriol

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT02477358

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Left Tooth Platelet Rich Fibrin; Right Tooth Implant Alone
Description: All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects will have platelet rich fibrin endodontic revascularization therapy will be applied to the left tooth socket only. The right tooth is implanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Right Tooth Platelet Rich Fibrin; Left Tooth Implant Alone
Description: All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects will have platelet rich fibrin endodontic revascularization therapy to the right tooth socket only. The left tooth is implanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.
Study: NCT02849080

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: semaglutide
Description: Oral administration once-daily.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: sitagliptin
Description: Oral administration once-daily.
Study: NCT04328428

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: acupuncture
Description: Use one acupuncture needle insert in a acupoint.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: acupuncture
Description: Use one acupuncture needle insert in a acupoint.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: acupuncture
Description: Use one acupuncture needle insert in a acupoint.
Study: NCT01388933

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TU-100
Description: 15g daily, orally as 5g three times daily for 8 consecutive weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Matching Placebo
Description: 15g as 5g three times daily, orally for 8 consecutive weeks
Study: NCT02895295

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Expert Recommendation
Description: Decision support tool that provides personalized information on the financial implications of enrolling in different plans and expert recommendations of particular plans.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Individual Analysis
Description: Decision support tool that provides personalized information on the financial implications of enrolling in different plans.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Usual Care
Description: Study subjects randomized to the control arm will receive information on how to download their prescription drug information from their electronic medical record and provided with a list of resources available in the community to help them choose a prescription drug plan.
Study: NCT02385565

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: high fat diet
Description: high fat diet as 10 % proteins, 30 % lipids, 60 % carbohydrates

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: normal fat diet
Description: high fat diet as 10 % proteins, 45 % lipids,45 % carbohydrates
Study: NCT02213588

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: AOX blend
Description: Antioxidant supplement

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT04303416

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Albumin solution
Description: plasma exchange with albumin, one per week for one month, then one per month for 5 months
Study: NCT00622492

Intervention type: OTHER
Intervention: echocardiography Doppler sonography, blood and urine sampling
Description: data registration and collection at standard intervals from directly before cannulation until 24 hours after decannulation from ECMO

Intervention type: OTHER
Intervention: echocardiography Doppler sonography, blood and urine sampling
Description: data registration and collection at standard intervals from directly before cannulation until 24 hours after decannulation from ECMO
Study: NCT00814723

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: fluvastatin
Description: 80 mg MR, 12 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Fluvastatin plus ezetimibe
Description: fluvastatin 80 mg MR plus ezetimibe 10 mg
Study: NCT04437836

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Evaluation of high dose rifampicin in children
Description: Evaluation of severity of adverse event from grade 1 to 5

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Evaluation of high dose rifampicin in children
Description: Evaluation of severity of adverse event from grade 1 to 5

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Evaluation of high dose rifampicin in children
Description: Evaluation of severity of adverse event from grade 1 to 5
Study: NCT01440634

Intervention type: OTHER
Group type: OTHER
Intervention: Supervised exercise Program
Description: Supervised exercise Program consist of six months of supervised, intermittent track walking. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month. During each exercise session, individuals will be encouraged to walk at a speed of approximately 2 mph until they achieve leg pain or discomfort on walking of moderate severity.Individuals are then allowed to have a brief period of standing or sitting rest to permit symptoms to resolve before they resume exercise.
Study: NCT02029274

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BAF312
Description: BAF312 was provided as film-coated tablets in strengths of 0.25, 0,5, 1 and 2 mg for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BAF312
Description: BAF312 was provided as film-coated tablets in strengths of 0.25, 0,5, 1 and 2 mg for oral administration.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BAF312
Description: BAF312 was provided as film-coated tablets in strengths of 0.25, 0,5, 1 and 2 mg for oral administration.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Matching placebo to BAF312 as tablets for oral administration.
Study: NCT04235166

Intervention type: OTHER
Intervention: Current risk scores
Description: Current risk scores for assessing the prognosis of acute upper gastrointestinal bleeding in cirrhosis were used.

Intervention type: OTHER
Intervention: New risk scores
Description: New risk scores for assessing the progress of acute upper gastrointestinal bleeding in cirrhosis was used.
Study: NCT00651300

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Parecoxib/Valdecoxib
Description: A single 40mg dose of intravenous (IV) parecoxib sodium administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of valdecoxib 40 mg (2 x 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: A single dose of IV saline (placebo) administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of placebo (2 x matching valdecoxib 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
Study: NCT02252107

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: decitabine
Description: Single arm study: the addition of 10 days (20 mg/m2) decitabine to the conditioning regimen prior to allogeneic hematopoietic transplantation.
Study: NCT04369846

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GM-XANTHO onitment
Description: Onitment application

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo onitment
Description: Onitment application
Study: NCT01307878

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: chemotherapy ± targeted therapy
Description: Chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.
Study: NCT01504139

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase
Description: when the follicles are over 12 mm FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark) is replaced by hCG (r-hCG, Ovitrelle,Merck-Serono, Hellerup,Denmark).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase
Description: hCG(r-hCG,Ovitrelle,Merck-Serono, Hellerup, Denmark) is given together with FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark) from the beginning of the FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark)stimulation.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase
Description: LH(r-LH, Luveris, Merck-Serono, Hellerup, Denmark) replaces progesterone and estradiol in the luteal phase.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase
Description: The usual dose of vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol (Estrofem; Novo Nordisk, Copenhagen, Denmark) is given in the luteal phase-
Study: NCT00869908

Intervention type: DRUG
Intervention: insulin aspart
Description: Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention type: DRUG
Intervention: insulin detemir
Description: Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Intervention type: DRUG
Intervention: biphasic insulin aspart
Description: Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Study: NCT01133704

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: sipuleucel-T

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: APC-Placebo
Study: NCT04845880

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2
Description: Blood level of spike protein (S) or the nucleocapsid (N) of SARS-CoV-2
Study: NCT00720070

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: positron emission tomography/computed tomography
Description: Patients undergo PET/CT scan

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: positron emission tomography/computed tomography
Description: Patients undergo PET/CT scan

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: therapeutic conventional surgery
Description: Patients undergo neck dissection

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: therapeutic conventional surgery
Description: Patients undergo neck dissection
Study: NCT02693457

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Drain
Description: One randomized knee will be assigned to receive an intra-articular drain procedure following bilateral total knee arthroplasty. The drain will be removed 24 hours post-operatively. The patient will be blinded to fluid output from intra-articular drain.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: No Drain
Description: The contralateral knee will be assigned to a placebo drain procedure following bilateral total knee arthroplasty. This will blind the patient as to which knee contains the functioning intra-articular drain. A non-suction/ non-functional subcutaneous drain will act as the placebo drain. This drain will not output any fluid and will also be removed 24 hours after post-operatively.
Study: NCT02475772

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin and doxorubicin
Description: The first 5 patients will receive doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 2.25 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 11.25 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 3 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 15 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. This schedule represents a three-step, 50% dose-escalation. Dose density will not be changed.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Cisplatin and doxorubicin
Description: intraperitoneal chemotherapy with cisplatin and doxorubicin in a dose-escalation scheme
Study: NCT00136214

Intervention type: DIAGNOSTIC_TEST
Intervention: MR brain and neuropsychiatric tests

Intervention type: DIAGNOSTIC_TEST
Intervention: MR brain and neuropsychiatric tests
Study: NCT03060369

Intervention type: DEVICE
Intervention: CareGuide™ device
Description: CareGuide™ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation.

Intervention type: DEVICE
Intervention: CareGuide™ device
Description: CareGuide™ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation.
Study: NCT02778022

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: PriCARE
Description: PriCARE is a group parent training program designed to improve child behavior, improve parent-child relationships, and decrease stress for parents. PriCARE utilizes the 3 P skills (Praise, Paraphrase and Point-out-Behavior) and includes a trauma and stress education component. The training starts with parenting skills focused on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second phase of the training teaches techniques for giving children effective commands in order to set age-appropriate limits. We piloted PriCARE and demonstrated promising findings. The PriCARE intervention has been slightly modified from the pilot version to increase engagement and attendance.
Study: NCT03114085

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capecitabine
Description: Capecitabine 1000mg/m2 po bid, d1-d14, every 21 days for a cycle;

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Apatinib
Description: Apatinib 500 mg po qd, d1-d21, every 21 days for one cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apatinib
Description: Apatinib 500 mg po qd, d1-d21, every 21 days for one cycle
Study: NCT03351088

Intervention type: PROCEDURE
Group type: OTHER
Intervention: DVC ligation
Description: Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy

Intervention type: PROCEDURE
Group type: OTHER
Intervention: DVC ligation
Description: Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy
Study: NCT03082469

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: CytoSorb
Description: Two consecutive 24h treatments with the CytoSorb-device
Study: NCT03974802

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: somofilcon A contact lens
Description: Contact Lens

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: fanfilcon A contact lens
Description: Contact Lens
Study: NCT04230343

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Self-benefit message
Description: A pamphlet consisting of a short text and an abstract figure. The top half of the pamphlet described the official criteria for qualifying to be in the risk group. Bottom half indicated that one can gain immunity against influenza by getting the vaccine and included a figure of one smiley face.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Other-benefit message
Description: A pamphlet consisting of a short text and an abstract figure. The top half of the pamphlet described the official criteria for qualifying to be in the risk group. Bottom half indicated that one can gain immunity against influenza by getting the vaccine, and gaining immunity would lower the chances of transmitting the disease to others. The figure included one smiley face surrounded by three other smiley faces.
Study: NCT01273909

Intervention type: PROCEDURE
Intervention: Perforator Flap Breast Reconstruction
Description: perforator flap breast reconstruction with or without vascularized lymph node transfer

Intervention type: PROCEDURE
Intervention: Perforator Flap Breast Reconstruction
Description: perforator flap breast reconstruction with or without vascularized lymph node transfer

Intervention type: PROCEDURE
Intervention: Vascularized Lymph Node Transfer
Description: perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction

Intervention type: PROCEDURE
Intervention: Vascularized Lymph Node Transfer
Description: perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
Study: NCT03263715

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tocilizumab Prefilled Syringe [Actemra]
Description: Weekly administration of Tocilizumab 162 mg subcutaneous from Baseline to Week 16.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebos
Description: Weekly administration of Placebo subcutaneous from Baseline to Week 16.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Glucocorticoids
Description: Rapidly tapered Glucocorticoid treatment. 20 mg/day of prednisone at randomization and a pre-specified taper regimen will be followed over 11 weeks: Week 0: 20 mg Week 1: 17,5 mg Week 2: 15 mg Week 3: 12,5 mg Week 4: 10 mg Week 5: 9 mg Week 6: 7 mg Week 7: 5 mg Week 8: 4 mg Week 9: 2 mg Week 10: 1 mg Week 11: 0 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Glucocorticoids
Description: Rapidly tapered Glucocorticoid treatment. 20 mg/day of prednisone at randomization and a pre-specified taper regimen will be followed over 11 weeks: Week 0: 20 mg Week 1: 17,5 mg Week 2: 15 mg Week 3: 12,5 mg Week 4: 10 mg Week 5: 9 mg Week 6: 7 mg Week 7: 5 mg Week 8: 4 mg Week 9: 2 mg Week 10: 1 mg Week 11: 0 mg