AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT04242875 — intervention group
Intervention type: OTHER
Intervention: Visual disturbance questionnaire.
Description: Questionnaire evaluating visual disturbances.
Study NCT00649480 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BALSALAZIDE DISODIUM CAPSULES, 750 MG
Description: 3x750mg, single dose fed
Study NCT00649480 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: COLAZAL® Capsules 750 mg
Description: 3x750mg, single dose fed
Study NCT00030654 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: bicalutamide
Study NCT00030654 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: docetaxel
Study NCT00030654 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: doxorubicin hydrochloride
Study NCT00030654 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: estramustine phosphate sodium
Study NCT00030654 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: flutamide
Study NCT00030654 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ketoconazole
Study NCT02037880 — intervention group
Intervention type: DEVICE
Intervention: Magnetic Resonance Imaging (MRI) of the brain
Study NCT00030654 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paclitaxel
Study NCT00030654 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: releasing hormone agonist therapy
Study NCT00030654 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vinblastine sulfate
Study NCT00338715 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PVI with Medtronic's Cardioblate BP2 radiofrequency catheter
Description: Ablation of the right and left pulmonary veins
Study NCT00349102 — intervention group
Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Free breathing
Description: Free breathing during conformal radiation
Study NCT00349102 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Breath holding
Description: Breath holding during conformal radiation
Study NCT03133897 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prednisone
Description: control group will receive 4 day treatment
Study NCT01374581 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Artemether/Lumefantrine
Description: Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk).~Weight in kg Number of tablet per dose Age 5 to \< 15 kg 1 tablet per dose 15 to \< 25 kg 2 tablets per dose 25 to \< 35 kg 3 tablets per dose
Study NCT01024751 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Bausch & Lomb Multi-Purpose Solution
Description: Lens care product for disinfecting lenses on a daily basis.
Study NCT01024751 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Ciba's Multi-Purpose Solution
Description: Lens care product for disinfecting lenses on a daily basis.
Study NCT03374345 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sipjeondaebo-tang Granule
Description: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
Study NCT01941628 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rocuronium
Description: Rocuronium 0.6 mg/kg will be used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade will be maintained until the suture of fascia of musculus rectus abdominis.
Study NCT03374345 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
Study NCT04622020 — intervention group
Intervention type: PROCEDURE
Intervention: Cervical Plexus Block with Local Anaesthesia
Description: Ultrasound guided intermediate cervical plexus block
Study NCT04622020 — intervention group
Intervention type: PROCEDURE
Intervention: Cervical Plexus Block with Depot Steroids
Description: Ultrasound guided intermediate cervical plexus block
Study NCT00955903 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Exercise
Description: Participants will participate in supervised exercise sessions
Study NCT00955903 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise
Description: Participants will participate in supervised exercise sessions
Study NCT00955903 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Reduced Calorie Diet
Description: Participants will follow a reduced calorie diet
Study NCT00955903 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Weight Maintenance Diet
Description: Participants will follow a weight maintenance diet
Study NCT01773538 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lactulose and rifaximin
Description: 3 months treatment. lactulose 25 Ml x3 per day. Rifaximin (550 mg) x 2 per day.
Study NCT01773538 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Branched Chain amino acids
Description: 30 grams of branched chain amino acids (Bramino) per day is given to the patients in the antiHE treatment arm along with lactulose and rifaximin.
Study NCT01773538 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Patients in the placebo-arm receives both placebo-Bramino, placebo-lactulose and placebo-rifaximin.
Study NCT02492217 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Adalimumab
Study NCT03810079 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Anodal transcranial direct current stimulation
Description: Neuromodulation of bilateral prefrontal areas using 2 mA tDCS delivered during 20 minutes via sponge electrodes on the scalp
Study NCT03810079 — intervention group
Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Anodal transcranial direct current stimulation
Description: Neuromodulation of bilateral prefrontal areas using 2 mA tDCS delivered during 20 minutes via sponge electrodes on the scalp
Study NCT01689740 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Active Placebo Dose MDMA (25 mg)
Description: Initial dose of 25 mg MDMA administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 12.5 mg MDMA 1.5 to 2.5 hours later.
Study NCT01689740 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Full Dose MDMA (125 mg)
Description: Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
Study NCT01689740 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Open Label Full Dose MDMA (125 mg)
Description: Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
Study NCT01689740 — intervention group
Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Psychotherapy
Description: Non-directive psychotherapy will be conducted throughout the study.
Study NCT01689740 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Psychotherapy
Description: Non-directive psychotherapy will be conducted throughout the study.
Study NCT01628510 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Dandle Roo/Dandle Wrap
Description: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when the infant is lying in the isolette or crib, but is taken out for hands on care times or when held.
Study NCT01628510 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Traditional NICU Positioning
Description: These methods aim at providing containment and flexion and may consist of interventions such as swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper®
Study NCT03327675 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: 68Ga-PSMA (HBED-CC) PET
Description: 68Ga-PSMA PET/MR
Study NCT02471508 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Body-mapping Tank-top Embedded with Biofeedback System
Description: In this study, the eligible subjects will be given tailor-made tank-top embedded with biofeedback system to wear it 8 hours daily. Monitor, observation and additional posture training sessions will be provided during the 6 months wearing period. The effectiveness of the biofeedback tank-top will be evaluated by pre-and post- treatment ultrasonic imaging device (measuring the angle of the spine) and electromyography muscle signal
Study NCT01182922 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Invitation letter
Description: Invitation letter sent 6 weeks prior to prespecified screening colonoscopy appointment date and followed by reminder letter within 3 weeks if no response is received.
Study NCT04598880 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Polyethylene glycol + ascorbate
Description: Pleinvue® is administered orally in 2 doses (3 sachets) as per SmPC within the previous 18 hours to colonoscopy intervention. First dose is administered at 9 pm on the day before intervention (sachet 1: MACROGOL 3350 100 g + SODIUM SULFATE ANHYDROUS 9 g + SODIUM CHLORIDE 2 g + POTASSIUM CHLORIDE 1 g). Second dose is administered 5 hours before intervention and it is composed by 2 sachets (sachet A: MACROGOL 3350 40 g + SODIUM CHLORIDE 3,2 g + POTASSIUM CHLORIDE 1,2 g; sachet B: SODIUM ASCORBATE 48,11 g + ASCORBIC ACID 7,54 g).
Study NCT04598880 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sodium picosulfate + magnesium citrate
Description: Citrafleet® is administered orally in 2 doses (2 sachets) as per SmPC within the previous 18 hours to colonoscopy intervention. First dose (sachet 1) is administered at 9 pm on the day before intervention. Second dose (sachet 2) is administered 5 hours before intervention. Sachets 1 and 2 have the same composition: SODIUM PICOSULFATE 10 mg + MAGNESIUM OXIDE 3,5 g + CITRIC ACID 10,97 g.
Study NCT04326985 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Autologous Mesenchymal Stem Cells Treatment (MSCs)
Description: The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.
Study NCT04326985 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hyaluronic acid (HA)
Description: The HA group patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.)
Study NCT00972387 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: CHO, CHO-P, CHO-CHO, PLA
Description: The CHO supplement will be administered during trial 1. The CHO-P will be administered during trial 2. The CHO-CHO supplement will be administered during trial 3. The PLA supplement will be administered during trial 4. This is the order of supplement administration for subjects randomly assigned to this order group.
Study NCT00972387 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: CHO-P, CHO-CHO, PLA, CHO
Description: The CHO-P supplement will be administered during trial 1. The CHO-CHO will be administered during trial 2. The PLA supplement will be administered during trial 3. The CHO supplement will be administered during trial 4. This is the order of supplement administration for subjects randomly assigned to this order group.
Study NCT00972387 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: CHO-CHO, PLA, CHO, CHO-P
Description: The CHO-CHO supplement will be administered during trial 1. The PLA will be administered during trial 2. The CHO supplement will be administered during trial 3. The CHO-P supplement will be administered during trial 4. This is the order of supplement administration for subjects randomly assigned to this order group.
Study NCT00972387 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: PLA, CHO, CHO-P, CHO-CHO
Description: The PLA supplement will be administered during trial 1. The CHO will be administered during trial 2. The CHO-P supplement will be administered during trial 3. The CHO-CHO supplement will be administered during trial 4. This is the order of supplement administration for subjects randomly assigned to this order group.
Study NCT01298180 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Growth hormone (Genotonorm® or Omnitrope®)
Description: drug : the treatment will be begun in progressive dose by beginning by ¼ of the dose the first week, then ½ of the dose the second week, then 3/4 of the dose the third week and total dose the fourth week.
Study NCT01298180 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: DEXA, blood tests, H.G.P.O, osseous age.
Description: SPW, GHD, SPW-B :~blood tests : centralized dosage H.G.P.O : adjusted to children's age.
Study NCT01298180 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: biopsy
Description: Biopsy : Cutaneous and fat tissue biopsy.
Study NCT04719013 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Evoke radiofrequency device
Description: Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
Study NCT02035787 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: Metformin added to standard non-surgical treatment with levonorgestrel-Releasing Intrauterine Device.
Study NCT01632332 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: HER-2/neu peptide vaccine
Description: Given ID
Study NCT01632332 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study NCT01803932 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Male-focused group violence prevention intervention
Study NCT01941628 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Succinylcholine
Description: Standard induction into general anesthesia with succinylcholine 1 mg/kg will be performed. No other muscle relaxant will be administered during the Caesarean section until surgeon would request it. In that case, according to general standards, dose of atracurium 0.25 mg/kg will be administered.
Study NCT01163149 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: asfotase alfa
Description: Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (total of 2.1 mg/kg/week)
Study NCT01163149 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: asfotase alfa
Description: Cohort 2: Daily SC injections of 0.5 mg/kg Asfotase Alfa (3.5 mg/kg/week total)
Study NCT01932996 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: nicotine patch plus nicotine gum/lozenge
Description: 12-week treatment with nicotine patch plus nicotine gum/lozenge
Study NCT01932996 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: nicotine patch plus nicotine gum/lozenge
Description: 12-week treatment with nicotine patch plus nicotine gum/lozenge
Study NCT01932996 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Intensive Alcohol Intervention
Description: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
Study NCT01374581 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Artesunate/Amodiaquine
Description: Age (Weight in Kg) Dose Treatment duration 2 to 11 months (= 4,5 to \< 9kg):1 tablet (25 mg/675mg) for 3 days~1 to 5 years (= 9 kg to \< 18 kg)1 tablet(25mg/67,5mg)for 3 days
Study NCT01374581 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Quinine + Clindamycin
Description: this arm consist to 7 days treatment of 60 patients with quinine tablet 125mg + clindamycin syrup as follow;~Quinine:~9 to \< 11 kg: ½ tablets 12 to \< 19 kg: 1 tablets per dose 20 to \< 27 kg: 1½ tablets per dose 28 to \< 35 kg: 2 tablets per dose~Clindamycin syrup:~10 mg/kg twice daily
Study NCT03451825 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Avelumab
Description: Participants received an intravenous infusion of avelumab 10mg/kg intervention (IV) once every 2 weeks until confirmed progression, death, unacceptable toxicity, or any criterion for withdrawal occurred.
Study NCT03451825 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Avelumab
Description: Participants received an intravenous infusion of avelumab 20mg/kg intervention (IV) once every 2 weeks until confirmed progression, death, unacceptable toxicity, or any criterion for withdrawal occurred.
Study NCT00092547 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: V501
Description: 0.5 mL intramuscular injection of V501
Study NCT00092547 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Comparator: Placebo
Description: 0.5 mL intramuscular injection of placebo
Study NCT02681887 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Melatonin
Description: Circadin, controlled release melatonin tablet 2mg by mouth each day before bedtime for 12 weeks
Study NCT02681887 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: placebo tablet identical to circadian
Study NCT01350700 — intervention group
Intervention type: OTHER
Intervention: Scars assessment & QOL
Description: Scar assessment and quality of life questionnaires
Study NCT02007239 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tocilizumab
Description: single dose of tocilizumab (8mg/kg intravenously) within 24 hours of administration of standard immunochemotherapy.
Study NCT02988986 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-228
Description: MTORC1/2 inhibitor
Study NCT02988986 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tamoxifen
Description: Non-steroidal anti-estrogen
Study NCT00670917 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: questionnaire administration
Study NCT00670917 — intervention group
Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: questionnaire administration
Study NCT00670917 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: acupressure therapy
Study NCT00670917 — intervention group
Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: acupressure therapy
Study NCT00670917 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: biopsy
Study NCT00670917 — intervention group
Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: biopsy
Study NCT00670917 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: bone marrow aspiration
Study NCT00670917 — intervention group
Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: bone marrow aspiration
Study NCT00670917 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: pain therapy
Study NCT00670917 — intervention group
Intervention type: PROCEDURE
Group type: SHAM_COMPARATOR
Intervention: pain therapy
Study NCT01371838 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ceftaroline
Description: Two consecutive infusions q12h for 5 to 7 days
Study NCT01371838 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ceftriaxone
Description: One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.
Study NCT04315363 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Motivational MRI and Behavioral Intervention
Description: Motivational messaging delivered during a functional brain MRI scan and with daily messaging
Study NCT03261544 — intervention group
Intervention type: PROCEDURE
Intervention: Proximal Femur Replacement
Description: The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique.
Study NCT03682991 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Aggressive Risk Factor Control
Description: 1. Sleep apnea screening, therapy is recommended if apopnea-hypopnea (AHI) index is greater than 15, with a target index of less than 5.~2. Counseling regarding alcohol reduction to 2 drinks/day for men, 1 drink/day for women, no binge drinking (>5 drinks at one setting).~3. Participation in a 12 week structured, home-based exercise program and nutritional counseling. Weight reduction will be emphasized through modification of diet and exercise.~4. Blood Pressure management to achieve a target systolic blood pressure (SBP) of \<120/80 mm/Hg~5. Smoking cessation facilitated through local resources already established at each site
Study NCT03682991 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard of Care
Description: Recommendations based on current guidelines
Study NCT04315363 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Control MRI and Behavioral Intervention
Description: Control messaging delivered during a functional brain MRI scan and with daily messaging
Study NCT02465034 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Transcranial Magnetic Stimulation
Description: Transcranial Magnetic Stimulation (TMS) will be performed using the Magstim BiStim\^2 paired pulse stimulator to measure transient cortical excitability. Single pulse transcranial magnetic stimulation applied at low frequencies (not greater than 0.25 hertz (Hz)) will be used. The may be repeated at multiple study visits. All five study visits will be completed within four weeks of the initial visit.