TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01559675

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hydrocortisone High Dose
Description: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydrocortisone Low Dose
Description: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3 IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD 2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed
Study: NCT03953469

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Passiflora incarnata
Description: One-time administration of 1/8 tsp solid extract Passiflora incarnata providing 900mg of Passiflora incarnata
Study: NCT01751100

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: HIV Test Offer
Description: HIV education and counseling from a trained Research Assistant and offering of a free rapid, oral HIV test

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: General Health Screen Offer
Description: A Research Assistant (RA) will provide health education on diabetes, hypertension, and HIV. The RA will then offer free blood pressure check, blood glucose measuring, rapid Hepatitis C (HCV) test, and a free, rapid oral HIV test.
Study: NCT03285269

Intervention type: DIAGNOSTIC_TEST
Intervention: Ultrasound Protocol
Description: Ultrasound of the inferior vena cava, heart and lungs.

Intervention type: DEVICE
Intervention: Bioreactance
Description: Bioreactance assessment using Cheetah Bioreactance Device (FDA Approved). Bioreactance is a non-invasive measure of cardiac output.

Intervention type: PROCEDURE
Intervention: Passive Leg Raise
Description: A passive leg raise involves placing the patient supine and raising the legs to simulate an intravenous fluid bolus.
Study: NCT04095182

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zebinix 400mg
Description: Zebinix 400mg group is administered with two Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo for Zebinix 400mg
Description: Placebo for Zebinix 400mg group is administered with two placebo for Zebinix 200mg tablets per day.~(Single dose: Day 1, Multiple dose: Day5\~11)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zebinix 800mg
Description: Zebinix 800mg group is administered with a Zebinix 800mg tablet per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo for Zebinix 800mg
Description: Placebo for Zebinix 800mg group is administered with a placebo for Zebinix 800mg tablets per day.~(Single dose: Day 1, Multiple dose: Day5\~11)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zebinix 1600mg
Description: Zebinix 1600mg group is administered with two Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5\~11)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo for Zebinix 1600mg
Description: Placebo for Zebinix 1600mg group is administered with two placebo for Zebinix 800mg tablets per day.~(Single dose: Day 1, Multiple dose: Day5\~11)
Study: NCT02155777

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: OrthoNovum 1/35
Study: NCT04093713

Intervention type: PROCEDURE
Group type: OTHER
Intervention: A novel technique to block the inferior alveolar nerve block using Mepivecaine with Levonordefrin
Description: blocking the inferior alveolar nerve using extroral landmarks
Study: NCT05140460

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Cultural Pride Reinforcement for Early School Readiness (CPR4ESR)
Description: The intervention entails distribution of a children's book with a cultural pride theme and the cultural pride parent book-sharing guide. Intervention participants select and receive a developmentally appropriate (baby, toddler, or preschool) book that features African American, Latino, Asian or diverse cultural pride perspectives.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Reach Out and Read (ROR)
Description: The control condition involves distribution of a standard ROR book and book-sharing advice. Distributed books are developmentally appropriate (baby, toddler, or preschool).
Study: NCT04977713

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Acupressure
Description: A researcher sat behind the women to comfortably access the sacral area and be in the appropriate position. The researcher then applied deep rotational pressure on the BL32 points until her nail bed colour changed to prevent any discomfort in the participants

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Shower
Description: During uterine contractions, these participants took a shower while standing, with a researcher on hand to assist her (average time: 20 minutes). The water's temperature was between 22°C and 26°C.
Study: NCT04198480

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JMT103
Description: 2 mg/kg subcutaneously (SC) every 4 weeks with a loading dose of 2 mg/kg SC on study days 8 and 15.
Study: NCT01591941

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Core-PAC
Description: Core position and control movement strategy (Core-PAC):~Do warm-up prior to 6 weeks of regular soccer training for peak flexion angles and peak abduction moments at the knee during a side-cut (SC) and an unanticipated side-cut (USC) prior to kicking a soccer ball and a side-hop (SH) task.
Study: NCT02652975

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: 24hour blood pressure
Description: 24 hour blood pressure measurement

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: 24hour blood pressure
Description: 24 hour blood pressure measurement
Study: NCT05335824

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: The platelet-rich plasma (PRP)
Description: Twenty ml of venous blood was drawn from each patient with the use of PRP tubes that contain anticoagulant citrate dextrose. The double-spin technique was used to prepare the PRP. The injection areas were anesthetized with lidocaine 2% with epinephrine 1/80000 and left for 10 minutes. 15 units (0. 15 mL) of PRP were injected interaligamentlly in the middle, distobuccal, and distopalatal areas of the distal surface of the upper canines (5 units in each area) together with submucosal injections buccally and palatally (100 units and 50 units~, respectively).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: The injectable platelet-rich fibrin (I-PRF) group
Description: Twenty ml of venous blood was drawn from each patient in this experimental group.~I-PRF was prepared with the use of 20 ml of blood drawn from the patient in dry sterile tubes without anticoagulant (quickly before coagulation starts) by following the centrifugation protocol requires one cycle only (700 RPM for 3 minutes) Injection procedures, sites, and time were similar to the PRP group.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: The control group
Description: NiTi closed-coil springs (American Orthodontics, Sheboygan, WI) were used to impose 150 g force from the first molar band hook to the bracket of canine on each side on 0.019\*0.025-in SS archwire Patients' follow-up appointments were two weeks intervals; at each visit, the force produced by the coil was checked and readjusted when needed in order to keep it at 150-g level and the appliances were examined for any deformation or change in the position because of chewing. Canine retraction continued until achieving Class I canine relationship.
Study: NCT03348540

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Attention Control Training
Description: Attention control training teaches participants that the emotional salience of cues (i.e., threatening or neutral) is not related to successful completion of the computerized response task, and thus, teaches participants to ignore irrelevant threat-related contingencies (Badura-Brack et al., 2015).

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Comparison Task
Description: Neutral- neutral stimuli prior to response task
Study: NCT03757819

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: tDCS
Description: Brain Stimulation
Study: NCT02652975

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: DEXA scan
Description: Measurements of body composition: Total body fat and fat free mass is measured by Dual Energy X-ray Absorptiometry (DEXA).

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: DEXA scan
Description: Measurements of body composition: Total body fat and fat free mass is measured by Dual Energy X-ray Absorptiometry (DEXA).

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: DEXA scan
Description: Measurements of body composition: Total body fat and fat free mass is measured by Dual Energy X-ray Absorptiometry (DEXA).

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Laboratory blood samples
Description: Fasting blood tests are drawn from an antecubital placed catheter (albumin, ALAT/ASAT, alkaline phosphatase, bilirubin, gammaglutamyl transferase, coagulation factors, red and white blood cells, creatinin, potassium, sodium, fasting lipids, fasting glucose, hemoglobin A1C, insulin, sex hormones, von Willebrand factor, low grade inflammation markers, DNA and RNA for later analyses, including relevant coding genes).~Further more urine samples to determine possible systemic impact of cardiovascular disease.~We will create a biobank containing urine and blood samples from participants for future research, provided that the participant gives her permission.~Responsibility for the biobank lies with the project responsible physician, Anders Bonde Jensen.
Study: NCT03757819

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: tDCS
Description: Brain Stimulation

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: SHAM
Description: Placebo device

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: SHAM
Description: Placebo device
Study: NCT03720717

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Baclofen 10mg
Description: Baclofen administration pre-operatively

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Baclofen 10mg
Description: Baclofen administration pre-operatively

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo administration

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo administration
Study: NCT00666952

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Booklet Decision Aid
Description: General educational booklet on gastrointestinal surgery developed by the NIH titled, 'Gastrointestinal Surgery for Severe Obesity'.
Study: NCT02255045

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meloxicam
Description: 1 Meloxicam Vaginal Ring (MVR) for 4-6 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Meloxicam
Description: 1 Meloxicam Vaginal Ring (MVR) for 4-6 days
Study: NCT01591941

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Core-PAC
Description: Core position and control movement strategy (Core-PAC):~Do warm-up prior to 6 weeks of regular soccer training for peak flexion angles and peak abduction moments at the knee during a side-cut (SC) and an unanticipated side-cut (USC) prior to kicking a soccer ball and a side-hop (SH) task.
Study: NCT03359850

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Niraparib
Description: Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Niraparib
Description: Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.
Study: NCT03998267

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Droobi
Description: A new mobile application, specifically built for the diabetes patients in Qatar with the help of local expertise.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard of care
Description: Standard of care including physicians, dietetics and diabetes educators support

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Standard of care
Description: Standard of care including physicians, dietetics and diabetes educators support
Study: NCT01075789

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lignocaine
Description: Lignocaine 10% solution administered intra nasally plus lignocaine 2% solution administered orally.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lignocaine
Description: Lignocaine 10% solution administered intra nasally plus lignocaine 2% solution administered orally.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Viscous, coloured, sucrose flavoured gel solution to match xylocaine viscous in appearance, normal saline administered intranasally to the nasal turbinates and nasopharynx.
Study: NCT02124213

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 30 mg PF-06412562
Description: Subject will receive a single dose of 30 mg PF-06412562

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-06412562
Description: The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PF-06412562
Description: The dose will be selected based on the results obtained for Cohort 1 and Cohort 2.~This Cohort is optional.
Study: NCT03895333

Intervention type: OTHER
Intervention: Audiological profiling and bone mineral densitometry measurement
Description: bone mineral densitometry measurements and hearing test patients, osteoporosis according to whether the hearing test will be analyzed.

Intervention type: OTHER
Intervention: Audiological profiling and bone mineral densitometry measurement
Description: bone mineral densitometry measurements and hearing test patients, osteoporosis according to whether the hearing test will be analyzed.
Study: NCT00950846

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Busulfan
Description: Day -9, -8, -7 and -6~Patients less than or equal to 12 kg: 1.1 mg/kg/dose IV every 6 hours for 16 doses total; patients \>12 kg: 0.8 mg/kg/dose IV every 6 hours for 16 doses.
Study: NCT03010228

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: VLA15 with Alum
Description: I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: VLA15 with Alum
Description: I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: VLA15 with Alum
Description: I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: VLA15 without Alum
Description: I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: VLA15 without Alum
Description: I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses
Study: NCT00950846

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytoxan
Description: (50 mg/kg/dose) will be given IV on Days -5, - 4, -3, and -2 over 2 hours (can be given over 1 to 4 hours as determined by the treating physician). The total dose to be given over 4 days is 200 mg/kg.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: 40 mg/m2/day IV over 1 hour for patients greater than 10 kg, or 1.3 mg/kg/day for patients less than or equal to 10 kg.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Cord Blood Stem Cell Infusion
Description: The cord blood stem cells will be infused on Day 0.
Study: NCT00165178

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: prednisone
Description: Induction Phase: Given orally or intravenously Days 0-28 Intensification Phase: Given orally Days 1-5 of each cycle Continuation Phase: Given orally Days 1-5 of each cycle
Study: NCT02255045

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Diclofenac Potassium
Description: 1 tablet 50 mg diclofenac every 12 hours for 4-6 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Oral
Description: 1 placebo tablet every 12 hours for 4-6 days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Oral
Description: 1 placebo tablet every 12 hours for 4-6 days

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Oral
Description: 1 placebo tablet every 12 hours for 4-6 days

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo Vaginal
Description: 1 placebo vaginal ring for 4-6 days

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Vaginal
Description: 1 placebo vaginal ring for 4-6 days
Study: NCT03673124

Intervention type: DRUG
Group type: OTHER
Intervention: Ribociclib
Description: 600 mg by mouth daily for 21 days followed by 7 days off treatment

Intervention type: DRUG
Group type: OTHER
Intervention: Letrozole
Description: 2.5 mg by mouth daily
Study: NCT03762642

Intervention type: PROCEDURE
Intervention: Mastectomy
Description: Removal of the whole breast

Intervention type: PROCEDURE
Intervention: Breast-Conserving Surgery
Description: Removal of the cancerous tissue only
Study: NCT00165178

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dexamethasone
Description: Intensification Phase: Given orally days 1-5 of each cycle Continuation Phase: Given orally days 1-5 pf each cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: doxorubicin
Description: Induction Phase: Intravenously on Days 0,1 Intensification Phase: Intravenously on Day 1 of each cycle

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: doxorubicin
Description: Induction Phase: Intravenously on Days 0,1 Intensification Phase: Intravenously on Day 1 of each cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: doxorubicin
Description: Induction Phase: Intravenously on Days 0,1 Intensification Phase: Intravenously on Day 1 of each cycle

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: doxorubicin
Description: Induction Phase: Intravenously on Days 0,1 Intensification Phase: Intravenously on Day 1 of each cycle

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: E. coli asparaginase
Description: Intensification Phase: In the muscle weekly. Dose will vary

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: E. coli asparaginase
Description: Intensification Phase: In the muscle weekly. Dose will vary

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vincristine
Description: Induction: Intravenously on days 0, 7, 14, 21 MLL Intensification Phase: Intravenously on Days 1, 8, 15, 22 CNS Therapy: Intravenously on Day 1 Intensification Phase: Intravenously on day 1 of each cycle Continuation Phase: Intravenously on Day 1 of each cycle

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: vincristine
Description: Induction: Intravenously on days 0, 7, 14, 21 MLL Intensification Phase: Intravenously on Days 1, 8, 15, 22 CNS Therapy: Intravenously on Day 1 Intensification Phase: Intravenously on day 1 of each cycle Continuation Phase: Intravenously on Day 1 of each cycle

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vincristine
Description: Induction: Intravenously on days 0, 7, 14, 21 MLL Intensification Phase: Intravenously on Days 1, 8, 15, 22 CNS Therapy: Intravenously on Day 1 Intensification Phase: Intravenously on day 1 of each cycle Continuation Phase: Intravenously on Day 1 of each cycle
Study: NCT01003470

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: acupuncture
Description: Xing Nao Kai Qiao Acupuncture

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: rehabilitation
Description: Kinesitherapy

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: acupuncture and rehabilitation
Description: Xing Nao Kai Qiao Acupuncture plus Kinesitherapy
Study: NCT01283009

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Inactive Substance
Description: Inactive Substance will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day).

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methylprednisolone
Description: Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day).
Study: NCT04025866

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Conventional rehabilitation
Description: 1h/day for 5 days/week of conventional rehabilitation for femur fracture

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Conventional rehabilitation
Description: 1h/day for 5 days/week of conventional rehabilitation for femur fracture

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Aerobic exercise
Description: 30 min/day of aerobic exercise with arm cycle ergometer added to 1h/day for 5 days/week of conventional rehabilitation for femur fracture
Study: NCT00909857

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)
Description: Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ethinyl estradiol, Levonorgestrel (Miranova)
Description: Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo Match to SH T00658ID
Description: Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo Match to SH D593B
Description: Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.