TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00618696

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: anti-CD45 monoclonal antibody AHN-12
Description: 150 mg/m\^2 cold antibody at Day 0

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: yttrium Y 90 anti-CD45 monoclonal antibody AHN-12
Description: Dose per scheduled level; 2.5-12.5 mCi/m\^2
Study: NCT04637464

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Early termination of empirical antibiotics
Description: Termination of empirical antibiotics for febrile neutropenia based on clinical parameters, regardless of neutrophile count.
Study: NCT01641926

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PEG-Intron™
Description: PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: PEG-Intron™
Description: PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: PEGASYS™
Description: PEGASYS subcutaneously (SC) once weekly for a total of 48 weeks

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: PEGASYS™
Description: PEGASYS subcutaneously (SC) once weekly for a total of 48 weeks
Study: NCT04367038

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Warm Acupressure, Cold Acupressure , Conventional Acupressure
Description: Acupressure is non-invasive, safe and effective.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Warm Acupressure, Cold Acupressure , Conventional Acupressure
Description: Acupressure is non-invasive, safe and effective.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Warm Acupressure, Cold Acupressure , Conventional Acupressure
Description: Acupressure is non-invasive, safe and effective.
Study: NCT02673710

Intervention type: OTHER
Intervention: No intervention
Description: Besides participant reported outcomes and a muscle strength test no interventions are administered, all treatment decisions are at the discretion of the physician and will be in line with local clinical practice and labeling
Study: NCT01865305

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec/insulin aspart 30
Description: Single dose administrated subcutaneously (s.c., under the skin).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec/insulin aspart 40
Description: Single dose administrated subcutaneously (s.c., under the skin).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec/insulin aspart 50
Description: Single dose administrated subcutaneously (s.c., under the skin).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec
Description: Single dose administrated subcutaneously (s.c., under the skin).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin aspart
Description: Single dose administrated subcutaneously (s.c., under the skin).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: biphasic insulin aspart 30
Description: Single dose administrated subcutaneously (s.c., under the skin) as comparator.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec/insulin aspart 40
Description: Single dose administrated subcutaneously (s.c., under the skin).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec/insulin aspart 50
Description: Single dose administrated subcutaneously (s.c., under the skin).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: biphasic insulin aspart 30
Description: Single dose administrated subcutaneously (s.c., under the skin).
Study: NCT01664520

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine infusion
Description: Both static and dynamic autoregulation are assessed first during propofol infusion, before commencement of dexmedetomidine infusion. Dexmedetomidine infusion is commenced with a dose of 0.7 μg/kg/h and propofol infusion is stopped concomitantly. After 2 hours dexmedetomidine infusion, the static and dynamic autoregulation are assessed. If there are no signs of worsening of autoregulation, then the dexmedetomidine infusion is increased to 1 μg/kg/h and after 2 hours the static and dynamic autoregulation are assessed again. However, if autoregulation worsens during dexmedetomidine infusion, it will be stopped and further testing with dexmedetomidine will not be carried out. If autoregulation does not worsen with the 1 μg/kg/h dose then the dose will be increased to 1.4 μg/kg/h. After 2 hours infusion the dynamic and static autoregulation are assessed again.~Blood samples for determining dexmedetomidine plasma concentration are collected alongside with the autoregulation assessments
Study: NCT02294630

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Surfactant
Description: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Surfactant
Description: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Surfactant
Description: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Surfactant
Description: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Study: NCT04040881

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Remote monitoring using smartphone accelerometer
Description: Patients will be instructed to carry the smartphone around their hips during waking hours, regardless of whether they are at home or outside (a nylon hip holster will be provided) and to keep it turned on at all times.~Daily steps will be recorded for at least seven days before the start of chemotherapy, and the median baseline number of daily steps will be calculated for each patient.~On the first day of chemotherapy, patients will receive side effect education as per standard of care. Patients will be instructed to continue carrying the smartphone daily as indicated for the entire duration of the first three chemotherapy cycles.~At the end of the follow-up period (or sooner in cases of early interruption of chemotherapy due to toxicity or disease progression; a change in chemotherapy regimen; or hospitalizations lasting ≥3 days), patients will rate their satisfaction with the intervention using a Likert-scale questionnaire and open-ended questions.
Study: NCT05103163

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Foot Reflexology
Description: Reflexology application is an energy balancing system with its own pressure technique that provides recovery by rubbing the reflex (nerve endings) points, stroking and applying pressure during squeezing movements. Thanks to the pressure and massage applie
Study: NCT04131478

Intervention type: GENETIC
Intervention: Pharmacogenetic testing
Description: Pharmacogenetic testing for TNF alfa

Intervention type: GENETIC
Intervention: Pharmacogenetic testing
Description: Pharmacogenetic testing for TNF alfa
Study: NCT01822938

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: incentive program for physical activity
Study: NCT02923102

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Aloysia citriodora extract
Description: 2 capsules with 200mg - daily dosage 400mg

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Maltodextrin
Description: 2 capsules with 200mg - daily dosage 400mg
Study: NCT00310895

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Imetelstat Sodium (GRN163L)
Description: Dose increase by 25% if tolerated infused over 2 hours
Study: NCT00992537

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec
Description: Insulin degludec single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: insulin degludec/insulin aspart
Description: Insulin degludec/insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: insulin aspart
Description: Insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).
Study: NCT03645135

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Goal elicitation
Description: Patients will be asked to list 2 goals for their visit
Study: NCT01746420

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rhPDGF-BB Injection
Description: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rhPDGF-BB Injection
Description: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rhPDGF-BB Injection
Description: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rhPDGF-BB Injection
Description: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: sodium acetate buffer (0 mg rhPDGF-BB)
Study: NCT02117908

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: RESMED AUTOSET S9
Description: Continuous positive pressure during surgery

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: RESMED AUTOSET S9
Description: Continuous positive pressure during surgery
Study: NCT03554863

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Nasal High Flow Oxygen
Description: Nasal High Flow Oxygen using Optiflow device of Fisher and Paykel

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Facial Mask
Description: Preoxygenation with facial mask
Study: NCT02158468

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Combined intrahospital pre- and postconditioning
Description: After admission to hospital 3 cycles of preconditioning with 5-min inflation and 5-min deflation of a blood-pressure cuff. After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Postconditioning
Description: After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)
Study: NCT00727324

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bovine intestinal alkaline phosphatase (BIAP)
Description: 30,000U/24h for 7 consecutive days via a duodenal catheter
Study: NCT01460160

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dasatinib
Description: Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
Study: NCT02544828

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Iron Sucrose 200mg
Description: Iron Sucrose 200mg is administered after anesthesia induction.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: placebo (normal saline) is administered after anesthesia induction
Study: NCT05806502

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Nω-hydroxy-nor-arginine
Description: Arginase inhibitor

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Nω-hydroxy-nor-arginine
Description: Arginase inhibitor
Study: NCT03833128

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Low Dose REN001
Description: Oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: High Dose REN001
Description: Oral

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: High Dose REN001
Description: Oral
Study: NCT01379027

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Pure self-help Internet CBT for depression
Description: Internet, CBT, Depression

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Guided self-help Internet CBT
Description: CBT, Depression, Website intervention, coaching

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Stepped-Care Internet CBT condition
Description: Depression CBT, Internet intervention
Study: NCT02424591

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ketamine
Description: Infusion at a rate of 10 mcg/kg/min

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo IV
Study: NCT02446795

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sunitinib
Description: Sunitinib: 50mg once daily orally for 4 weeks followed by 2 weeks off treatment (either at 8 a.m. or at 8 p.m.)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Sunitinib
Description: Sunitinib: 50mg once daily orally for 4 weeks followed by 2 weeks off treatment (either at 8 a.m. or at 8 p.m.)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Isoquercetin
Description: Isoquercetin: 225mg twice a day(at 08 a.m. and at 4 p.m)/Isoquercetin: 450 mg twice a day(at 08 a.m. and at 4 p.m).

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo: 225mg twice a day(at 08 a.m. and at 4 p.m)/Placebo: 450 mg twice a day(at 08 a.m. and at 4 p.m).
Study: NCT02038686

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: PFN-A

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: PFN-A
Study: NCT01488565

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine and eltrombopag
Description: Standard: azacitidine D1-5, 8\&9, until loss of clinical benefit. Experimental: eltrombopag at a dose ranging from 50-300mg for 6 months, continuing only in those deriving clinical benefit.
Study: NCT02481492

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: No flip technique of Shang Ring circumcision
Description: Measure the diameter of the penis with a scale plate of holes, the diameter of the ring was accordance with the glands, inner ring is placed into foreskin cavity, apply the outer ring on the skin covering inner ring, clamp the out ring and cut the redundant foreskin; Ring is detached spontaneously.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Flip technique of Shang Ring circumcision
Description: Measure the diameter of the penis with a scale plate of holes, the diameter of the ring was accordance with the penis, inner ring is placed around the penis, flip foreskin over the inner ring, apply the outer ring on the skin covering inner ring, clamp the out ring and cut the redundant foreskin; Remove the ring 7days postoperatively.
Study: NCT01555801

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: submucosal injection needle ; EUS
Description: The patients will accepted submucosal injection of 5ml saline followed by ordinary endosonography(EUS) before surgery or endoscopic dissection.

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: ordinary endosonography(EUS)
Description: These patients will be accepted ordinary EUS followed by surgery or endoscopic dissection.
Study: NCT01552122

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Odanacatib
Description: Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Alendronate
Description: Alendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Placebo (odanacatib)
Description: One compressed tablet administered orally, once-a-week, for 24 months.

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Cholecalciferol (Vitamin D3)
Description: Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.
Study: NCT03389451

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ga-68 PSMA-HBED-CC PET
Description: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
Study: NCT01552122

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Cholecalciferol (Vitamin D3)
Description: Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Calcium carbonate
Description: Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Calcium carbonate
Description: Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Placebo (alendronate)
Description: One compressed tablet administered orally, once-a-week, for 24 months.
Study: NCT01461330

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: DASH diet plus exercise
Description: DASH diet adapted to the usual diet of Brazilian type 2 diabetic patients = prescription of a normocaloric diet including fruits, vegetables, grain products, low fat dairy foods, legumes, without sugar, and with limited fat~Exercises: the recommended physical activity will consist of using a pedometer during the experimental period.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: ADA diet
Description: Adoption of ADA diet.
Study: NCT02659917

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Glass ionomer
Description: Application of preventive agent

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Glass ionomer cement
Description: Application of preventive agent

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: -Glass ionomer-
Description: Atraumatic Restorative Treatment
Study: NCT04435977

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cabozantinib 60 MG
Description: • The assigned dose for study treatment is 60 mg qd. Two dose reductions will be permitted (Table 2):~* 60 mg qd to 40 mg qd (level 1)~* 40 mg qd to 20 mg qd (level 2)
Study: NCT02394340

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Omeprazole 40 mg
Description: Oral capsule to be taken as per the instructions regarding proper dosing technique.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Luliconazole Cream 1%
Description: Topical cream to be applied as per the instructions regarding proper study drug application technique.
Study: NCT02856724

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PGE2
Description: 10 mg PGE2 vaginal ovul(Propess)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: PGE2
Description: 10 mg PGE2 vaginal ovul(Propess)
Study: NCT04008771

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: SeeQ CdSe 655 ALT
Description: SeeQ CdSe 655 Alt is a sterile colloidal solution of coated CdSe nanoparticles in a borate buffer suitable for intraocular injection.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: SeeQ CdSe 655 ALT
Description: SeeQ CdSe 655 Alt is a sterile colloidal solution of coated CdSe nanoparticles in a borate buffer suitable for intraocular injection.
Study: NCT01585753

Intervention type: DRUG
Intervention: NRTI + PI
Description: tenofovir zidovudine abacavir lamivudine emtricitabine ritonavir darunavir atazanavir lopinavir fosamprenavir

Intervention type: DRUG
Intervention: maraviroc + PI
Description: maraviroc ritonavir darunavir atazanavir lopinavir fosamprenavir

Intervention type: DRUG
Intervention: maraviroc + NRTI
Description: maraviroc tenofovir zidovudine abacavir lamivudine emtricitabine
Study: NCT01497964

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cabazitaxel XRP6258
Description: Pharmaceutical form: solution for infusion Route of administration: intravenous
Study: NCT01265979

Intervention type: PROCEDURE
Intervention: Whole body diffusion MRI
Description: These studies will be performed on a 3 Tesla (T) MR system. A major advantage of 3T compared to 1.5T is the improved signal to noise ratio that allows whole-body studies to be faster and without application of external antennas, which greatly improves patient comfort.
Study: NCT03637140

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Simulated Altitude (FiO2: 15.1%)
Description: Inhalation of deoxygenated air through a altitude simulator (Altitrainer), for approx. 1 hour. given by a facemask.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Simulated Altitude (FiO2: 15.1%)
Description: Inhalation of deoxygenated air through a altitude simulator (Altitrainer), for approx. 1 hour. given by a facemask.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Shamed Hypoxia (FiO2: 20.9)
Description: Inhalation of unmodified air through an altitude simulator (Altitrainer) for approximately 1 hour given by a facemask

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Shamed Hypoxia (FiO2: 20.9)
Description: Inhalation of unmodified air through an altitude simulator (Altitrainer) for approximately 1 hour given by a facemask
Study: NCT02837939

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Human derived Transfer factor
Description: One dose (the content of one amp.) of lyophilised drug contains:~Leucocyte dialysatum 200 x 10 to the power of 6 (Lyophilized dialysate from 200 million leukocytes) pH = 7.8 to 9 after reconstitution (dissolving) of drug~To be administered subcutaneously as follows:~12 doses TF in total:~* 3 x TF in first week: day 1,3,5~* 2 x TF in week 2: day 8 , 11~* 1 xTF in week 3 and 4 : day 15, 22~* 1 x TF once a month up to 6 month

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Aqua pro injectione 4ml ampules for subcutaneous injection
Description: 12 doses in total:~* 3 doses in first week: day 1,3,5~* 2 doses in week 2: day 8 , 11~* 1 dose in week 3 and 4 : day 15, 22~* 1 dose once a month up to 6 month