TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01682837

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks
Study: NCT00665717

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pravastatin
Description: 40 mg tablet; QD; 4 days

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Raltegravir
Description: 400mg tablet; BD 4 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pravastatin and raltegravir
Description: pravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days
Study: NCT01125436

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Cholecalciferol
Description: 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Cholecalciferol
Description: Weekly placebo plus 800 calcium alone
Study: NCT01598389

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Feeding study
Description: In a crossover design, siblings were served dinner once a week for 3 weeks. Across conditions, siblings were served the same dinner, but, 25 minutes before dinner, they either consumed in full or did not consume one of two preloads that varied in energy density. On the day when no preload was consumed, eating in the absence of hunger was assessed after dinner and defined as the number of calories consumed from snacks. Habitual dietary intake was assessed using 24-hour dietary recalls.
Study: NCT01788137

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: chemotherapy (CHOP)
Description: Treatment Arm A (CHOP): cyclophosphamide(C), 750mg/m2 for injection on day1; doxorubicin(H), 50 mg/m 2 for injection on day1; and Vincristine(O), 1.4 mg/ m2 for injection on day1, prednisone(P) 60 mg/m2 orally on days 1 to 5. The therapy was repeated every 21 days for a total of 6 cycles

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: chemotherapy(c-ATT)
Description: Treatment Arm B (c-ATT):Alternative 3 regimen to be used sequentially(CHOPB→IMVP-16→DHAP).The therapy was repeated every 21 days for a total of 6 cycles.
Study: NCT02674074

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: infrared thermography
Description: measurement of corneal temperature by infrared thermography before and after cold provocation
Study: NCT01040676

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Automated Telephone Nutrition Support
Description: See Intervention Group description.
Study: NCT03047473

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: avelumab
Description: add on of avelumab 10mg/kg IV to standard therapy
Study: NCT04229277

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: optical coherence tomography
Description: comparison of four imaging technologies in skin tumour diagnosis
Study: NCT05147285

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: stabilization exercises
Description: Patients will be applied only online supervised stabilization exercises three times a week for 8 weeks.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: combined exercises
Description: Patients will be applied online supervised aerobic exercise training and stabilization exercises.Aerobic exercises will be performed for 8 weeks, for 30-45 minutes, at 65-75% of the maximum heart rate, 3 days a week, on the days when stabilization exercises are not performed.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Physical activity recommendations
Description: The importance of physical activity will be explained to the patients and appropriate physical activity recommendations will be made.
Study: NCT00902291

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AGS-1C4D4
Description: IV infusion

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Gemcitabine
Description: IV infusion

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: IV infusion
Study: NCT02677675

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Intervention (reminder module)
Description: Reminder module (delivered via SMS and telephone call reminders)
Study: NCT02996370

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: papilla fill index
Description: The clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: papilla fill index
Description: The clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: crestal bone loss
Description: Crestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: crestal bone loss
Description: Crestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: probing depth
Description: The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: probing depth
Description: The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Modified sulcus bleeding index
Description: Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Modified sulcus bleeding index
Description: Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.
Study: NCT00754130

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Placebo tablets before every meal (q.a.c) Treatment period is 5 days.
Study: NCT02996370

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Modified plaque index
Description: Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Modified plaque index
Description: Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.
Study: NCT03252574

Intervention type: OTHER
Group type: OTHER
Intervention: A
Description: AIR+ Smart Mask Only

Intervention type: OTHER
Group type: OTHER
Intervention: A
Description: AIR+ Smart Mask Only

Intervention type: OTHER
Group type: OTHER
Intervention: B
Description: AIR+ Smart Mask with micro-ventilator

Intervention type: OTHER
Group type: OTHER
Intervention: B
Description: AIR+ Smart Mask with micro-ventilator
Study: NCT04816422

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Proprioceptive neuromuscular facilitation
Description: rocedure~1. Bilateral upper extremity pattern for trunk by Chopping, Lifting~2. Bilateral lower extremity pattern for trunk.~3. Trunk lateral flexion.~4. Combination patterns for the trunk by Upper and lower trunk flexion, Upper trunk flexion with lower trunk extension, Upper and lower trunk extension, Upper trunk extension with lower trunk flexion.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Conventional treatment
Description: Group 2 has received conventional trunk exercise program for 45 min/day, 4 days~/ week for the period of 4 weeks the intervention includes static and dynamic functional trunk movement and strengthening exercise to the trunk muscles which includes motor developmental patterns, basic trunk movement, trunk-arm linked movements, trunk-leg linked patterns in sitting, transfer activities, with 2 minutes rest in between the repetition of each set, Progression will be made by increasing the repetition and resistance According to individual ability.
Study: NCT03178019

Intervention type: OTHER
Intervention: Laser-Doppler methods
Description: This was a cross-sectional study in which participants were subjected to a screening phase before being eligible to participate in the study. All subjects were submitted to Laser-Doppler methods (assessment of microcirculatory blood flow), bioimpedance analysis (assessment of body composition), venous blood collections (laboratory analysis), and Finometer Pro (assessment of heart rate variability and blood pressure variability).
Study: NCT01682837

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks
Study: NCT01682837

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Potassium magnesium citrate powder
Description: 1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
Study: NCT01296152

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: depo-medroxyprogesterone acetate
Description: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
Study: NCT01964898

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Behavioral Activation (BA)
Description: 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Standard Smoking Cessation Counseling
Description: 1 hour of in hospital counseling based on clinical guidelines

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Standard Smoking Cessation Counseling
Description: 1 hour of in hospital counseling based on clinical guidelines

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nicotine patch
Description: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine patch
Description: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Printed Self-help materials for Smoking Cessation
Study: NCT03577119

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Full-fat yogurt
Description: Controlled diet that includes three daily servings of whole (3.25% fat) yogurt.

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Non-fat yogurt
Description: Controlled diet that includes three daily servings of fat-free yogurt.
Study: NCT03180983

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: multimodal intervention
Description: Investigators will propose an online training. In addition, investigators will make phone calls to nursing home interlocutor between two nursing home visits. The tools of this intervention will consist on posters , quiz about bacteriuria and urinary tract infection (UTI) and algorithm to help nurse's reasoning when UTI is suspected.
Study: NCT02014649

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 20 mg laninamivir octanoate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 40 mg laninamivir octanoate
Study: NCT02889536

Intervention type: OTHER
Intervention: Focus group interviews
Description: Focus group interviews. Two groups with patients referred to repair of parastomal bulging and three groups with patients attending the outpatient stoma clinics
Study: NCT01682837

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
Study: NCT02233881

Intervention type: DRUG
Intervention: Atrovent® - inhalets
Study: NCT01682837

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
Study: NCT02641171

Intervention type: OTHER
Intervention: Specimen sampling
Description: exhaled air samples blood samples fecal samples
Study: NCT00479765

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: OncoGel (ReGel/Paclitaxel)
Description: OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.
Study: NCT02294552

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine monophosphate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine monophosphate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine monophosphate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tacrolimus

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tacrolimus

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mycophenolate mofetil

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Mycophenolate mofetil
Study: NCT01682837

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
Study: NCT02294552

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Allogeneic hematopoietic stem cell transplantation

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Allogeneic hematopoietic stem cell transplantation

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Allogeneic hematopoietic stem cell transplantation
Study: NCT02971332

Intervention type: PROCEDURE
Intervention: Stapled Transanal Rectal Resection
Description: The prolapsed tissue is pulled out through the CAD using e gauze pad and Allis forceps; this allows us to identify the extent of the prolapse to be resected. Four to five parachute stitches are then apposed circumferentially, like parachute cords, at the apex of the prolapse, in order to control the tissue during resection. The prolapse is then opened longitudinally at 3 o'clock with the electric scalpel between two Kocher clamps. Two traction stitches are applied at the deep vertex of the prolapse, one for each Kocher apex.~The longitudinal opening then allows the surgeon to begin circumferential resection of the rectum by pulling on the parachute stitches. This maneuver is performed counterclockwise using an average of 4-6 recharges, with care to always place the stapler at the base of the prolapse. The resected specimen was always inspected before the end of the procedure.
Study: NCT03952663

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: inferior alveolar nerve lateralization and dental implant placement.
Description: inferior alveolar nerve lateralization for placement of sufficiently long dental implants.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: inferior alveolar nerve lateralization and dental implant placement.
Description: inferior alveolar nerve lateralization for placement of sufficiently long dental implants.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: platelet rich fibrin membrane around the nerve
Description: platelet rich fibrin membrane is prepared from the patient's blood and placed around the nerve.
Study: NCT01682837

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
Study: NCT01283373

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DSTP3086S
Description: DSTP3086S administered intravenously

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DSTP3086S
Description: Escalating intravenous dose
Study: NCT04742816

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: IHX-CL measurements
Description: The distribution of measured IHX-CL values and other continuous variables will be assessed to ensure a parametric distribution.

Intervention type: DRUG
Group type: OTHER
Intervention: Iohexol
Description: Iohexol clearance measurement
Study: NCT01638923

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: EV/DNG (Qlaira, Natazia, BAY86-5027)
Description: 2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo. A blister card consists of 28 pills, taken orally once a day for 7 cycles of 28 days each.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: Matching placebo to be taken orally daily for 7 cycles of 28 days each.