TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00828802

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide, Decitabine
Description: Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide, Decitabine
Description: Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide, Decitabine
Description: Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide, Decitabine
Description: Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lenalidomide, Decitabine
Description: Decitabine 20mg/m2 over one hour IV for 5 days, with cycles repeated every 28 days. Lenalidomide given orally on Days 1-21 followed by 7 days of rest at various dose escalated cohorts (5 mg, 10mg, 15mg, 20 mg, 25 mg)
Study: NCT03423446

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Telotristat Ethyl
Description: Telotristat ethyl (TE) 250 mg (1 x 250-mg tablet), single dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Telotristat Ethyl
Description: Telotristat ethyl (TE) 250 mg (1 x 250-mg tablet), single dose
Study: NCT01621256

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ancrod
Description: Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Saline solution
Description: Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Study: NCT04472481

Intervention type: DRUG
Group type: OTHER
Intervention: Ergocalciferol 1.25 mg tablet
Description: weekly 50000 IU of Vitamin D2 (Ergocalciferol 1.25 mg tablet) given orally group II
Study: NCT02406573

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Crest® Sensi-Stop™ Strips
Study: NCT00978419

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rosuvastatin
Description: Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo administered every day for up to 28 days
Study: NCT00633178

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Group interpersonal therapy (IPT)
Description: Group IPT will include weekly treatment sessions with a psychiatrist for 12 weeks. The sessions will focus on overcoming relationship problems associated with depression. The first two and last sessions will be alone with the psychiatrist and the remaining sessions will be with a group of five to eight other pregnant women.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Treatment as usual (TAU)
Description: TAU will include referrals to outpatient treatment, which may include cognitive behavioral psychotherapy, insight-oriented psychotherapy, and/or antidepressant medication. TAU participants receiving psychotherapy will attend 12 weekly treatment sessions comparable to the IPT group sessions; treatment for TAU participants receiving medication for their depression may last longer than 12 weeks.
Study: NCT02291783

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HTL0009936
Description: Single dose

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: HTL0009936 placebo
Description: Placebo single dose
Study: NCT04548700

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone
Description: Drug: Liposomal mitoxantrone hydrochloride (12 mg/m2, 15 mg/m2, 18 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.~Drug: Cyclophosphamide (750 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.~Drug: Vincristine (1.4 mg/m2 with 2 mg as the maximum dose) will be administered by an intravenous injection on day 1 of each 28-day cycle.~Drug: Prednisone (100 mg/d) will be taken orally from day 1 to day 5 of each 28-day cycle.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dose-expansion stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone
Description: Drug: Liposomal mitoxantrone hydrochloride (at RP2D) will be administered by an intravenous infusion on day 1 of each 28- or 21-day cycle.~Drug: Cyclophosphamide (750 mg/m2) will be administered by an intravenous infusion on day 1 of each 28- or 21-day cycle.~Drug: Vincristine (1.4 mg/m2 with 2 mg as the maximum dose) will be administered by an intravenous injection on day 1 of each 28- or 21-day cycle.~Drug: Prednisone (100 mg/d) will be taken orally from day 1 to day 5 of each 28- or 21-day.
Study: NCT04222894

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Plant-based diet
Description: Weekly instructions will be given to the participants in the intervention group about following vegan diet.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Control Diet
Description: Participants will be asked to continue their usual diets for the 12-week study period.
Study: NCT02316353

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: C1-esterase inhibitor

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: C1-esterase inhibitor
Study: NCT01101958

Intervention type: DEVICE
Group type: OTHER
Intervention: Chartis System
Description: The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways.

Intervention type: DEVICE
Group type: OTHER
Intervention: Endobronchial Valve (EBV) Treatment
Description: The endobronchial valve is designed to induce target lobe volume reduction.
Study: NCT01098253

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Adherence Intervention
Description: Factors affecting adherence are addressed using a problem solving process.
Study: NCT01585779

Intervention type: DEVICE
Intervention: Contour 3D® implant for tricuspid valve repair
Description: Tricuspid annuloplasty ring

Intervention type: DEVICE
Intervention: Tri-Ad® implant for tricuspid valve repair
Description: Tricuspid annuloplasty ring
Study: NCT03840044

Intervention type: OTHER
Group type: OTHER
Intervention: Cold air exercise test
Description: Subjects will perform a submaximal 90 minutes exercise test in a controlled cold air environment (-5°C, 60% relative humidity) in a climate chamber with evaluation pre§/during\*/post§ of heart rate (HR)§\* and blood pressure (BP)§\*, spirometry§\*, PNIF§, FeNO§, electrocardiogram (ECG)§\*, body \& exhaled air temperature§\*, capsaicin cough threshold test§, histamine bronchial challenge test§, and sampling of nasal fluid§, induced sputum§, and venous blood§.

Intervention type: OTHER
Group type: OTHER
Intervention: Cold air exercise test
Description: Subjects will perform a submaximal 90 minutes exercise test in a controlled cold air environment (-5°C, 60% relative humidity) in a climate chamber with evaluation pre§/during\*/post§ of heart rate (HR)§\* and blood pressure (BP)§\*, spirometry§\*, PNIF§, FeNO§, electrocardiogram (ECG)§\*, body \& exhaled air temperature§\*, capsaicin cough threshold test§, histamine bronchial challenge test§, and sampling of nasal fluid§, induced sputum§, and venous blood§.
Study: NCT01034982

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD9668
Description: 20 mg
Study: NCT02713126

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: administered orally or inhaled, taken every 4 hours or 3 times per day during waking hours for 12 weeks

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sodium Nitrite
Description: administered orally or inhaled, 40 mg, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Study: NCT01034982

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD9668
Description: 20 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD9668
Description: 60 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZD9668
Description: 60 mg
Study: NCT02644096

Intervention type: OTHER
Group type: OTHER
Intervention: counselling and support after discharge from hospital
Description: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR
Study: NCT00540241

Intervention type: DRUG
Intervention: Pemetrexed
Description: in-label use
Study: NCT04169984

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Myofunctional Therapy
Description: Isometric, isokinetic and isotonic exercises for the upper airway muscles.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Exercises that do not alter the function or morphology of the upper airway.
Study: NCT02026674

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: FloRite
Description: Disposable home use urine flow meter.
Study: NCT03046927

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ergocalciferol
Description: Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
Study: NCT01766804

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Bovine Colostrum
Description: The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks.

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Study: NCT02092636

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: NIR/US Diagnostic Group
Description: Patients receiving an ultrasound-guided biopsy will participate in one study visit on the day of the biopsy. The NIR/US scan will be completed immediately prior to the biopsy procedure and takes about 5-10 minutes to perform.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: NIR/US Neoadjuvant Chemotherapy Group
Description: Patients may have the NIR/US scan performed at the time of their initial ultrasound-guided biopsy. In addition, patients in this group may also have NIR/US performed according the schedule in Table 1. The number of NIR/US study visits for these subjects will vary from 1-11 depending on the subject's treatment regimen. The expected duration of study participation for these patients is approximately 6 months.

Intervention type: OTHER
Group type: OTHER
Intervention: NIR/US Process Validation Group
Description: Patients who present with visible lumps at initial ultrasound but do not have ultrasound visible lumps on the day of the biopsy procedure will not require a biopsy. NIR/US scan will be performed. Data from the NIR/US scan will be used to validate instrument measurements.
Study: NCT00573612

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Motivational Interviewing
Description: Subjects will receive Motivational Interviewing telephone counseling.
Study: NCT02590003

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Carboplatin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nab-paclitaxel

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nab-paclitaxel
Study: NCT03495219

Intervention type: PROCEDURE
Intervention: Esophageal Manometry
Description: A catheter inserted through the nares, post appropriate anesthetization. The subject is then given 8 - 10 sips of water or semi viscous fluid during the routine study. At the conclusion of the clinical portion of the examination the manometer catheter is typically removed by the technician at that point. For the purposes of this research study the catheter will remain in place to examine pressures specifically at the lower end of the esophagus during various breathing patterns and training activities to see if pressures can be increased with instruction.
Study: NCT01517711

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tramadol
Description: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
Study: NCT01120002

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Tamibarotene
Description: Two Tamibarotene 2 mg or placebo tablet per day, once daily.
Study: NCT02713126

Intervention type: DEVICE
Group type: PLACEBO_COMPARATOR
Intervention: Accelerometer
Description: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Accelerometer
Description: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Cardiac Exercise Training
Description: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Cardiac Exercise Training
Description: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
Study: NCT03751449

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Educational Intervention
Description: Receive nutrition education

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Educational Intervention
Description: Receive nutrition education

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise Intervention
Description: Complete home-based aerobic and resistance exercise program

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Exercise Intervention
Description: Complete home-based aerobic and resistance exercise program

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Quality-of-Life Assessment
Description: Ancillary studies

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Quality-of-Life Assessment
Description: Ancillary studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Questionnaire Administration
Description: Ancillary studies

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Questionnaire Administration
Description: Ancillary studies
Study: NCT00677469

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cholestyramine
Description: 2 grams BID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cholestyramine
Description: 1 gram BID

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo powder
Description: 1 gram BID
Study: NCT01120002

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Two Tamibarotene 2 mg or placebo tablet per day, once daily.
Study: NCT03800797

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Loxoprofen sodium hydrogel patch
Description: 100 mg per day

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Loxoprofen sodium tablet
Description: 60 mg t.i.d.
Study: NCT01471470

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel, Capecitabine, Cisplatin, Bevacizumab
Description: Bevacizumab 7.5mg/kg IV (D1) Docetaxel 60 mg/m2 IV (D1) Cisplatin 60 mg/m2 IV (D1) Xeloda 1,875 mg/m2/day/bid PO (D1-D14)
Study: NCT02349659

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Implantation with the commercially available Axium neurostimulator
Study: NCT03714984

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pre operative exercise
Description: After randomization participants will be allocated in two groups. The educational pelvic floor intervention group will receive two months before surgery a physiotherapy visit were will be explain to patients and care giver the pelvic floor anatomy and biomechanics and how perform the exercises to be follow at home focusing on pelvic muscles awareness and contraction.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Control Group
Description: The control group will be just informed about the study protocol and will not receive any pre-operative intervention.
Study: NCT02183493

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: BI 1356

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 1356
Study: NCT01682317

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Eating Frequency
Description: Thirty adults will be provided an 8-week standard lifestyle intervention, that includes a 1200-1500 kcal/day, \< 30% energy from fat dietary prescription, and a physical activity goal of 200 minutes/week. Participants will be randomized to one of two conditions differing in EF using a prescription we have tested previously. One condition will limit the number of eating bouts/day to three (Three Meal), while the second condition will consume at least 100 kcal every 2 to 3 hours which should lead to approximately 6 eating bouts/day (Grazing).

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Eating Frequency
Description: Thirty adults will be provided an 8-week standard lifestyle intervention, that includes a 1200-1500 kcal/day, \< 30% energy from fat dietary prescription, and a physical activity goal of 200 minutes/week. Participants will be randomized to one of two conditions differing in EF using a prescription we have tested previously. One condition will limit the number of eating bouts/day to three (Three Meal), while the second condition will consume at least 100 kcal every 2 to 3 hours which should lead to approximately 6 eating bouts/day (Grazing).
Study: NCT01374321

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TRO40303
Description: 6 mg/kg, peripheral IV, single dose just before balloon inflation, slow bolus (35ml/min)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: single dose just before balloon inflation by slow bolus (35ml/min, peripheral IV)
Study: NCT00942370

Intervention type: DEVICE
Intervention: non invasive mechanomyographic device based on a 3 axes accelerometer
Description: This biomedical research consists specifically in the simultaneous acquisition of:~* EMG and MMG Signals of rectus abdominis of the abdomen,~* Respiratory flow,~* An electrocardiogram (ECG).~These acquisitions will be conducted on 16 healthy volunteers according to a standardized protocol, at rest and during voluntary cough and various physical exercises often resulting in urinary leakage in the incontinent person.
Study: NCT02574078

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nivolumab

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Bevacizumab

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pemetrexed

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pemetrexed

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pemetrexed

Intervention type: OTHER
Group type: OTHER
Intervention: Best Supportive Care
Description: Palliative radiation, palliative surgery and/or other best supportive care treatments

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: nab-Paclitaxel

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Paclitaxel

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Docetaxel

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Gemcitabine

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Erlotinib

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erlotinib

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Crizotinib

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Carboplatin
Study: NCT03085459

Intervention type: BEHAVIORAL
Intervention: work Time
Description: nurse got qualification certificate and the working time

Intervention type: BEHAVIORAL
Intervention: work Time
Description: nurse got qualification certificate and the working time

Intervention type: BEHAVIORAL
Intervention: work Time
Description: nurse got qualification certificate and the working time

Intervention type: BEHAVIORAL
Intervention: work Time
Description: nurse got qualification certificate and the working time
Study: NCT01702805

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Liberal Cell Transfusion

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Restricted red cell transfusion
Study: NCT00062855

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Skin Biopsy

Intervention type: GENETIC
Group type: EXPERIMENTAL
Intervention: Gene Modified Neuroblastoma Cells
Description: The first two injections will be given at week 1 and week 2 (i.e., separated by one week). Patients will then have a two-week rest and the remaining two injections will be given (again separated by one week) at week 4 and week 5.~A complete evaluation for evidence of toxicity and response will be performed at week 8 (after a 3 week rest).~At the 8 week (month 2) evaluation, in the absence of progressive disease requiring therapy without excessive toxicity and if more transduced cells are available, the patient will have the option to receive four additional SC injections each separated by 1 month at the higher of the two dosage levels they originally received.