TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00574847

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Escitalopram
Description: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
Study: NCT01855750

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ibrutinib
Description: 560 mg capsules administered by mouth once daily (21-day cycles)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 4 matched capsules administered by mouth once daily (21-day cycles)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Rituximab
Description: 375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: 375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Cyclophosphamide
Description: 750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Doxorubicin
Description: 50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Study: NCT04668963

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: MIRROR THERAPY
Description: patients were seated on a chair, with the mirror positioned between the upper limbs perpendicular to the subject's midline and with the unaffected upper limb facing the reflective surface. Following the physiotherapist indications, the patients observed the reflection of their unaffected limb while performing the following movements with the both arms, the affected one as good as possible: flexion and extension of the shoulder, elbow, wrist and finger, prone supination of the forearm.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: MIRROR THERAPY
Description: patients were seated on a chair, with the mirror positioned between the upper limbs perpendicular to the subject's midline and with the unaffected upper limb facing the reflective surface. Following the physiotherapist indications, the patients observed the reflection of their unaffected limb while performing the following movements with the both arms, the affected one as good as possible: flexion and extension of the shoulder, elbow, wrist and finger, prone supination of the forearm.
Study: NCT00424164

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lapatinib ditosylate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lapatinib ditosylate

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tamoxifen citrate
Study: NCT02234037

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Decitabine
Description: Decitabine will be administered intravenously at dose of 20mg/m² on 5 consecutive days every 28 days (1 cycle = 28 days) for a total of 2 cycles according to standard practice. Cycle 2 will proceed on time despite cytopenias, given that patients are not expected to be in remission after only 1 cycle of decitabine.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise
Description: Each patient will participate in 2-3 exercise sessions per week supervised by a physical therapist. Each exercise session will comprise \> 10 minutes of muscle strengthening, \> 10 minutes of aerobic exercise (treadmill walking or cycling), \> 10 minutes of stretching/range of motion exercises, and up to 10 minutes of individualized functional exercise (determined based on patient's reported deficits/targets in activities of daily living).
Study: NCT03560076

Intervention type: OTHER
Intervention: SBIRT Training and Implementation Strategies
Description: A train-the-trainer approach will be used to train site coordinators on the SBIRT process and implementation strategies.
Study: NCT00424164

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: tamoxifen citrate

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Study: NCT01855750

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: 50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Vincristine
Description: 1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: 1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Prednisone (or equivalent)
Description: 100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle
Study: NCT00424164

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Study: NCT01855750

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone (or equivalent)
Description: 100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle
Study: NCT01298466

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pregabalin
Description: The investigator will administer pregabalin in a flexible dose-escalation regimen as follows: 150 mg per night for 1 week, 300 mg per day for 1 week, 450 mg per day for 1 week, then 600 mg per day through to the end of the study. Patients may change the dose of medication based on individual response and tolerability as determined by the investigator.
Study: NCT02649647

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Conventional resection
Description: The conventional technique requests an excision of at least 10 cm of bowel proximal to the tumor, and the sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Proximally extended resection
Description: The modified technique requests an excision of the whole sigmoid colon and rectum proximal to the tumor, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.
Study: NCT03312166

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Compression device
Description: interventions on patient are :~* surgical excision of ear lobe keloid~* application of compression device on sutured skin
Study: NCT02993900

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Image-Guided Brachytherapy
Description: Brachytherapy will be precisely inserted with the assistance of magnetic resonance (MRI) scans
Study: NCT03006575

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: split-course radiotherapy
Description: split-course chest radiation at 40-51 Gy/10-17f and 15-24 Gy/5-8f

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: concurrent chemotherapy
Description: weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
Study: NCT03270488

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laser
Description: Laser (power of 3.0w).

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Laser (power 0,0w)
Study: NCT02154659

Intervention type: DEVICE
Group type: OTHER
Intervention: 24hr pH monitoring

Intervention type: DEVICE
Group type: OTHER
Intervention: 24hr pH monitoring
Study: NCT03977688

Intervention type: DEVICE
Intervention: Cytokin Adsorption
Description: Haemadsorption with Cytokin Adsorber (Cytosorb)
Study: NCT03630887

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
Description: Forced-air warming will be applied in the preanesthetic room during different time periods.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
Description: Forced-air warming will be applied in the preanesthetic room during different time periods.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: WarmTouch Model 5900, Covidien Ltd, Mansfield, USA
Description: Forced-air warming will be applied in the preanesthetic room during different time periods.
Study: NCT00875901

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Peripherally located lung tumor
Description: 12 cobalt gray equivalent per fraction for 4 fractions, 2-3 treatments per week (every other day), over 2 weeks for a total of 48 cobalt gray equivalent (Fractions at lest 40 hours apart)

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Centrally located lung tumor
Description: 6 cobalt gray equivalent per fraction for 10 fractions, 5 treatments per week over 2-3 weeks for a total of 60 cobalt gray equivalent (no more than one fraction per calendar day)
Study: NCT02282384

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: oseltamivir
Description: They will be assessed for eligibility at the clinics and those randomized to the intervention will receive oseltamivir 75 mg orally twice daily for 5 days within 72 hours of symptom onset. Participants randomized to the control group will receive calcium carbonate placebo pills twice daily for five days within 72 hours of symptom onset. For patients with a known creatinine clearance \< 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT05264584

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Isotonic saline
Description: All patients will receive a continuous intravenous infusion of isotonic saline at a rate of 0.5 mL/kg/h for at least 2 to 12 hours before the procedure and continued to receive it 6 to 24 hours afterward.

Intervention type: DRUG
Group type: OTHER
Intervention: Isotonic saline
Description: All patients will receive a continuous intravenous infusion of isotonic saline at a rate of 0.5 mL/kg/h for at least 2 to 12 hours before the procedure and continued to receive it 6 to 24 hours afterward.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: N-acetyl cysteine
Description: all the patients will receive 600 mg orally twice daily ,on the day before and the day of exposure to contrast or a single periprocedural dose (within 4 hours of contrast exposure) 1200 mg .

Intervention type: DRUG
Group type: OTHER
Intervention: N-acetyl cysteine
Description: all the patients will receive 600 mg orally twice daily ,on the day before and the day of exposure to contrast or a single periprocedural dose (within 4 hours of contrast exposure) 1200 mg .

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Febuxostat 80 MG
Description: All patients will receive a continuous intravenous infusion of isotonic saline at a rate of 0.5 mL/kg/h for at least 2 to 12 hours before the procedure and continued to receive it 6 to 24 hours afterward.
Study: NCT00632970

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Raltegravir
Description: 1, 400mg tablet twice a day, with Truvada 1 tablet once a day

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lopinavir/Ritonavir
Description: 2 tablets twice a day, with Truvada 1 tablet once a day

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Truvada
Description: 1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Truvada
Description: 1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)
Study: NCT03180502

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: IMRT (Intensity-Modulated Radiation Therapy)
Description: Undergo IMRT

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Proton Beam Radiation Therapy
Description: Undergo proton beam radiation therapy

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Temozolomide
Description: Chemotherapy drug

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: Chemotherapy drug
Study: NCT03650608

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cohort 1: HL217 Ophathalmic Solution QD
Description: Cohort 1 (Once a day)
Study: NCT02363400

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MEP
Description: Adjuvant Chemotherapy
Study: NCT01554215

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Mom Power Intervention Group
Description: attachment-based parenting program for parents in community setting led by trained and experienced facilitators.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Mom Power Attentional Control Group
Description: at home control, weekly mailings
Study: NCT01113528

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Regenerative therapy (omega 3 PUFA plus low dose aspirin)
Description: Comparison between regenerative bone graft alone and bone graft + Omega-3 and low dose aspirin

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Sugar pill
Description: 3 times daily
Study: NCT01211691

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: KB004, Monoclonal Antibody
Study: NCT05149066

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: #KindGirlsInACTion
Description: 9-session weekly cognitive-behavioural intervention to promote psychological well-being and prevent body image and eating-related disordered behaviours.
Study: NCT00681798

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Vandetanib
Description: 100mg/300mg

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Vandetanib
Description: 100mg/300mg

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Vandetanib
Description: 100mg/300mg

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Vandetanib
Description: 100mg/300mg
Study: NCT02984098

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dextrose
Description: before heel lance, 2ml oral dextrose gel 25%or 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dextrose
Description: before heel lance, 2ml oral dextrose gel 25%or 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale
Study: NCT02984696

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 1 mg of transdermal estradiol daily and 10mg of oral MPA
Study: NCT01602939

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cladribine and pegylated interpheron alpha-2a
Description: Cladribine (0.07 mg/Kg/day) s.c for 5 consecutive days each month for a total of 6 months.Cladribine daily doses could be increased up to 0.14 mg/Kg in the fourth, fifth and sixth cycles of therapy if no objetive response is achieved after the third cycle.~Pegylated Interpheron alpha-2a (1 mcgr/Kg) s.c weekly for a total of 6 months.
Study: NCT02157974

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Byetta 5Mcg Pen Injection
Description: 10 participants will receive 2 doses of Byetta, one at 7 PM the night prior to metabolic study and the second 30 min before ingestion of glucola
Study: NCT03781622

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: WOLF Thrombectomy Device
Description: Mechanical thrombectomy for the neurovasculature
Study: NCT00679081

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: CelTx
Description: Single application; split-mouth design

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Autologous sub-epithelial connective tissue graft
Description: Single application; split-mouth design
Study: NCT03643250

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Smaller Portion Size and Standard Appeal (non-divided plate)
Description: Food with Smaller Portion Size and Standard Appeal on a non-divided plate

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Smaller Portion Size and Enhanced Appeal (divided plate)
Description: Food with Smaller Portion Size and Enhanced Appeal on a divided plate

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Larger Portion Size and Standard Appeal (non-divided plate)
Description: Food with Larger Portion Size and Standard Appeal on a non-divided plate

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Larger Portion Size and Enhanced Appeal (divided plate)
Description: Food with Larger Portion Size and Enhanced Appeal on a divided plate

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Smaller Portion Size and Standard Appeal (divided plate)
Description: Food with Smaller Portion Size and Standard Appeal on a divided plate
Study: NCT04303221

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercise
Description: The exercises will be performed three times a week (Mondays, Wednesdays and Fridays), lasting 60 min, 10 minutes of warm-up, 40 min of multisensory exercises, and 10 min of final relaxation, for 12 weeks.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercise
Description: The exercises will be performed three times a week (Mondays, Wednesdays and Fridays), lasting 60 min, 10 minutes of warm-up, 40 min of multisensory exercises, and 10 min of final relaxation, for 12 weeks.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercise
Description: The exercises will be performed three times a week (Mondays, Wednesdays and Fridays), lasting 60 min, 10 minutes of warm-up, 40 min of multisensory exercises, and 10 min of final relaxation, for 12 weeks.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercise
Description: The exercises will be performed three times a week (Mondays, Wednesdays and Fridays), lasting 60 min, 10 minutes of warm-up, 40 min of multisensory exercises, and 10 min of final relaxation, for 12 weeks.
Study: NCT00545428

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Rhinoplasty
Description: Mastoid bone autograft for dorsal nasal augmentation
Study: NCT04855279

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: neutral sodium fluoride
Description: Topically applied

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: ACP-CCP gel
Description: Topically applied

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: nano-hydroxyapatite solution
Description: Topically applied

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: glycerine
Description: Topically applied
Study: NCT01724515

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Lipid infusion and muscle biopsies
Description: Subjects will undergo a baseline muscle biopsy, a lipid infusion for 5 hours (60 ml/hr), and a muscle biopsy after the lipid infusion.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Lipid infusion and muscle biopsies
Description: Subjects will undergo a baseline muscle biopsy, a lipid infusion for 5 hours (60 ml/hr), and a muscle biopsy after the lipid infusion.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Lipid infusion and muscle biopsies
Description: Subjects will undergo a baseline muscle biopsy, a lipid infusion for 5 hours (60 ml/hr), and a muscle biopsy after the lipid infusion.
Study: NCT03904381

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 5-fluorouracil
Description: 5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 5-fluorouracil
Description: 5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: 5-fluorouracil
Description: 5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Transconjunctival needling
Description: Transconjunctival needling was administered according to predetermined criteria.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Transconjunctival needling
Description: Transconjunctival needling was administered according to predetermined criteria.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Transconjunctival needling
Description: Transconjunctival needling was administered according to predetermined criteria.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Transconjunctival revision
Description: Transconjunctival revision was administered according to predetermined criteria.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Transconjunctival revision
Description: Transconjunctival revision was administered according to predetermined criteria.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Transconjunctival revision
Description: Transconjunctival revision was administered according to predetermined criteria.
Study: NCT01745679

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ceftriaxone treatment
Description: ceftriaxone will be administered à high dose : \> or equal to 75mg/kg/day or 4 gr/day
Study: NCT03022643

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Interpersonal Social Rhythms Psychotherapy
Description: The treatment involves 8-weeks of individual psychotherapy. Weekly sessions will be 60-minute long and will take place at the Pain Research Center. The treatment focuses on 1) the link between life events, pain severity, sleep disturbances, fatigue, and mood, 2) social and behavioral rhythms and sleep-wake disturbances, 3) identification and management of rhythm dysregulation and the triggers for it, 4) allowing and facilitating the mourning of the loss healthy self, 5) identification and appropriate management of symptoms.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bright Light Device
Description: All patients will be provided with a bright light device (Re-Timer) and will be instructed to use it in the first 2-hours of the day (for a minimum of 30 minutes) throughout the 8-week treatment period.
Study: NCT00957021

Intervention type: DEVICE
Group type: OTHER
Intervention: Triathlon® PS Total Knee System
Description: Triathlon® PS Total Knee system
Study: NCT01462708

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [18F]MK-9470
Description: Subjects will be injected with 10 mCi, and not to exceed 11 mCi (not \>10% of 10 mCi limit)of \[18F\]MK-9470, followed by PET imaging.
Study: NCT02376881

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erythropoietin
Description: 20,000 IU epo IV infusion in 100 ml normal saline in 2 hr for 3 successive days

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: 100 ml normal saline in 2 hr for 3 successive days
Study: NCT01804244

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TMC278
Description: 1 25-mg tablet \[27.5 mg as the hydrochloride salt) taken orally (by mouth) within 10 minutes after completion of a standardized breakfast on Day 1.