TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03345277

Intervention type: OTHER
Intervention: Continuous Temperature monitoring
Description: Residents in a long term care facility will wear a thermometer continuously for 3 months, measuring their body temperature
Study: NCT00272792

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sapropterin Dihydrochloride
Description: Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120-240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120-240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
Study: NCT01783210

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Specific Therapeutic Lifestyle Changes program in pregnancy
Description: TLC Program includes diet and mild physical activity. The TLC comprises 1500 kcal/day (3 main meals and 3 snacks) composed of 55% carbohydrate, 20% protein, and 25% fat. The dietitian adds an 200 kcal/day for obese or 300 kcal/day for overweight. The exercise intervention is focused on increasing walking. All participants are advised to participate in 30 min of moderate intensity activity at least 3 days a week. Subjects wear a pedometer waist during walking session for the assessment of the adherence to the physical activity program. Women are told to consider using the talk test (being able to maintain a conversation during activity) to monitor exercise intensity, and to record the frequency and duration of the activity on a diary . Follow-up is performed at 16, 20, 28, 36 weeks.

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Dietary and behavioral counselling in pregnancy
Description: The Control group receives only a simple nutritional booklet about a lifestyle and healthy diet during pregnancy without explicit caloric restriction, in accordance with Italian Guidelines for a healthy diet during pregnancy, compatible with a recommended nutritional intake.~30 minutes counseling session about the appropriate gestational weight gain (GWG) at term for each different BMI category is performed. Moreover, the importance of the limited GWG for preventing unfavorable maternal-neonatal outcomes related to excessive weight gain is explained. Women are scheduled to have a follow-up at 16, 20, 28, 36 weeks.
Study: NCT04257019

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Lavender oil
Description: Inhalation of Lavender oil

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Almond oil
Description: Inhalation of Almond oil

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Water
Description: Inhalation of water
Study: NCT04375436

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: NTRX-07-SDD
Description: NTRX-07-SDD for oral administration

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: NTRX-07-SDD
Description: NTRX-07-SDD for oral administration
Study: NCT04003298

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Electric toothbrush
Description: Electric toothbrush and power interdental device

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Control
Description: Oscillating-rotating
Study: NCT00020566

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: doxorubicin hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: doxorubicin hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: etoposide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: etoposide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: etoposide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ifosfamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ifosfamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ifosfamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: melphalan
Description: Given orally and IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vincristine sulfate
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vincristine sulfate
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vincristine sulfate
Description: Given IV

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: autologous hematopoietic stem cell transplantation
Description: Given IV

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: conventional surgery
Description: Given to patients deemed to require it

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: conventional surgery
Description: Given to patients deemed to require it

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: conventional surgery
Description: Given to patients deemed to require it

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Description: Given to patients deemed to require it

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Description: Given to patients deemed to require it
Study: NCT00372762

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Bumetanide
Description: Equivalent dose to pre-existing furosemide will be used

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: furosemide
Description: 20mg to 80mg orally once or twice daily
Study: NCT00020566

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Description: Given to patients deemed to require it
Study: NCT01911299

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Choline
Description: 5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water
Study: NCT00367198

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Pro-Stat
Description: two separate oral ingestions of nutrition supplement (either 30 ml per serving or at 60 ml per serving) during the hemodialysis session

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Pro-Stat
Description: two separate oral ingestions of nutrition supplement (either 30 ml per serving or at 60 ml per serving) during the hemodialysis session
Study: NCT00390416

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin
Description: Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
Study: NCT01399749

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Implantation of autologous cells
Description: Implantation of autologous ASC or chondrocytes, 1 million per cm² lesion, covered by autologous periosteal membrane

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Implantation of autologous cells
Description: Implantation of autologous ASC or chondrocytes, 1 million per cm² lesion, covered by autologous periosteal membrane
Study: NCT03325556

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo, tablets, once daily by mouth

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pimavanserin 34 mg
Description: Pimavanserin 34 mg total daily dose, tablets, once daily by mouth

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pimavanserin 20 mg
Description: Pimavanserin 20 mg total daily dose, tablets, once daily by mouth
Study: NCT03332472

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Telemedicine group
Study: NCT00750308

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: placebo matching tadalafil

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: placebo matching tadalafil

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: placebo matching tadalafil

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: placebo matching tadalafil

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: placebo matching tadalafil

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: placebo matching tadalafil

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: placebo matching tadalafil

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: placebo matching tadalafil

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: placebo matching tadalafil

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: placebo matching tadalafil

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: placebo
Description: placebo matching tadalafil
Study: NCT03734666

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Mindfulness Based Relapse Prevention - Smoking and Alcohol
Description: Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cognitive Behavioral Therapy
Description: Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.
Study: NCT04944719

Intervention type: DIAGNOSTIC_TEST
Intervention: nasopharyngeal aspirate
Description: nasopharyngeal aspirate to determinate colonization by streptococcus pneumoniae

Intervention type: DIAGNOSTIC_TEST
Intervention: nasopharyngeal aspirate
Description: nasopharyngeal aspirate to determinate colonization by streptococcus pneumoniae
Study: NCT01612039

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ASP3291
Description: Tablet, 1,000 mg (four 250-mg tablets), twice a day, 8 weeks

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Matching placebo tablets
Study: NCT03201211

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Blood sampling
Description: A volume of approximately 20 mL of whole blood should be drawn from each subject, at each study visit, for antibody determination and assay validation/development.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Blood sampling
Description: A volume of approximately 20 mL of whole blood should be drawn from each subject, at each study visit, for antibody determination and assay validation/development.
Study: NCT03332472

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Conventional group
Study: NCT03215524

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: DCdP
Description: Daratumumab, Cyclophosphamide, Dexamethasone, Pomalidomide

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: DCd+P
Description: Daratumumab, Cyclophosphamide, Dexamethasone, + Pomalidomide added only at first confirmed biochemical progression
Study: NCT02690207

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Herpes Zoster Vaccine GSK1437173A
Description: Intramuscular injection
Study: NCT01204697

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: docetaxel
Description: 75 mg/m2 intravenously every 3 weeks for 4 cycles

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: erlotinib [Tarceva]
Description: 150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: erlotinib [Tarceva]
Description: 150 mg/day orally as monotherapy
Study: NCT03987334

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Virtual Reality Treatment
Description: Experimental Group (VRT) subjects will undergo Virtual Reality Motor Control exercises based on augmented feedback of their performance.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Control Group
Description: Control Group (CT) subjects will undergo the same treatment of VRT subjects in terms of intensity, time and type, but with the VR turned off.
Study: NCT03201211

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Blood sampling
Description: A volume of approximately 20 mL of whole blood should be drawn from each subject, at each study visit, for antibody determination and assay validation/development.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2.
Description: 2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2.
Description: 2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
Study: NCT03896984

Intervention type: DRUG
Intervention: Radium-223 (Xofigo, BAY88-8223)
Description: Ra-223 was approved by the FDA in May 2013 for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Intervention type: DRUG
Intervention: Abiraterone
Description: Abiraterone is a CYP17 inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2011, and for patients with metastatic high-risk castration-sensitive prostate cancer in 2018.

Intervention type: DRUG
Intervention: Abiraterone
Description: Abiraterone is a CYP17 inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2011, and for patients with metastatic high-risk castration-sensitive prostate cancer in 2018.

Intervention type: DRUG
Intervention: Enzalutamide
Description: Enzalutamide is an androgen receptor inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2012, with warning and precautions added in 2017 regarding the risk of seizure and encephalopathy.

Intervention type: DRUG
Intervention: Enzalutamide
Description: Enzalutamide is an androgen receptor inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2012, with warning and precautions added in 2017 regarding the risk of seizure and encephalopathy.
Study: NCT01967836

Intervention type: DEVICE
Group type: OTHER
Intervention: Glad Press 'n Seal
Description: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering
Study: NCT04337242

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: B-DIT
Description: Blended Dynamic Interpersonal Therapy

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: B-CBT
Description: Blended Cognitive Behavioral Therapy

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: DIT
Description: Dynamic Interpersonal Therapy

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Cognitive Behavioral Therapy
Description: CBT
Study: NCT01444820

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: hypofractionation
Description: Centres using IMRT will use the dose painting technique to treat the prostate + proximal 1-cm SV to 6800 cGy in 25 fractions while the pelvic lymph nodes will receive 4500 cGy in 25 fractions. For patients with T3b, the whole SV is to be treated to 6800 cGy. Institutions using 3D-CRT will deliver the required dose to the pelvic volume (including pelvic lymph nodes and boost volume) - 4500 cGy - and a concomitant boost to the prostate and proximal 1-cm (or the whole SV if involved) SV to 6800 cGy.

Intervention type: RADIATION
Group type: OTHER
Intervention: conventional
Description: The first phase: whole pelvis including the prostate and regional lymph nodes treated with 4400 cGy in 22 fractions.~The second phase: prostate + proximal 1-cm SV treated with 3200 cGy in 16 fractions.~For patients with T3b, the whole SV is to be treated to 7600 cGy.
Study: NCT04603001

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY3410738
Description: Oral LY3410738

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY3410738
Description: Oral LY3410738

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY3410738
Description: Oral LY3410738

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY3410738
Description: Oral LY3410738

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY3410738
Description: Oral LY3410738

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY3410738
Description: Oral LY3410738

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY3410738
Description: Oral LY3410738

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY3410738
Description: Oral LY3410738

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: Oral venetoclax

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Venetoclax
Description: Oral venetoclax

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: Subcutaneous or intravenous azacitidine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azacitidine
Description: Subcutaneous or intravenous azacitidine
Study: NCT04083417

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Phenoxymethylpenicillin
Description: tablet PcV 1000 mg x 3 for 10 days

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: No antibiotic treatment
Description: No prescription of antibiotics
Study: NCT03326245

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methylphenidate Pill
Description: Oral methylphenidate (60 mg) given 30 minutes prior to bolus \[11C\]raclopride

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oral Placebo
Description: Oral PL will be given 30 minutes prior to bolus \[11C\]raclopride injection

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Oral Placebo
Description: Oral PL will be given 30 minutes prior to bolus \[11C\]raclopride injection

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Intravenous Placebo
Description: Intravenous Placebo given 30 minutes post bolus injection of \[11C\]raclopride.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Intravenous Placebo
Description: Intravenous Placebo given 30 minutes post bolus injection of \[11C\]raclopride.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Intravenous methylphenidate
Description: Intravenous methylphenidate 0.25 mg/kg in 3ml sterile saline given 30 minutes post bolus injection of \[11C\]raclopride.
Study: NCT03302897

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: LEP-F1 + GLA-SE
Description: Investigational vaccine

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: LEP-F1 + GLA-SE
Description: Investigational vaccine
Study: NCT04287972

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: DPC
Description: The anterior fat pad is dissected until the left crura is visible, pars flaccida is open and the right crura exposed. Phreno-oesophageal ligament is sectioned starting from the right crura. Posterior and anterior vagal nerve are recognized before the oesophageal dissection. An intra-abdominal oesophagus lengths of 2 or 3 cm is obtained in order to reduce tension. Left and right crura are sutured with 2 or 3 non absorbable 2-0 stitches; an additional anterior stitch is posed if necessary to calibrate hiatus size without oesophageal deviation.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: LSG
Description: After omental section close to gastric insertion, gastric stapling is realised with triple line endo stapler (normally 5 or 6 re-loads). The gastrectomy begins 5-6 cm from the pylorus; gastric fundus is totally resected keeping a distance of 5-10 mm from oesophagus. Any bleeding on staple line is controlled with surgical clips or coagulator.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: LSG
Description: After omental section close to gastric insertion, gastric stapling is realised with triple line endo stapler (normally 5 or 6 re-loads). The gastrectomy begins 5-6 cm from the pylorus; gastric fundus is totally resected keeping a distance of 5-10 mm from oesophagus. Any bleeding on staple line is controlled with surgical clips or coagulator.
Study: NCT01792167

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Second Step Curriculum
Description: social emotional learning program for 6th-8th graders. 15 50 minutes lessons in 6th grade, 13 50 minute lessons in 7th and 8th grade. covers empathy, perspective taking, anger management, impulse control, problem-solving, alcohol and drug prevention, sexual harassment, prejudice, bully prevention, bystander intervention
Study: NCT00960544

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capecitabine
Description: Routine administration of twice daily dosing for days 1-14 of a 21-day cycle.
Study: NCT01581684

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 411034
Description: Low dose solution for oral administration
Study: NCT03497442

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Brimonidine Tartrate
Description: Topical brimonidine tartrate will be applied to one half of each participant's face. A randomization process will be used to determine which side of the face each participant will apply treatment to. The untreated side of the face will receive a placebo vehicle. Patient and clinician will be blinded to treatment side.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Vehicle Gel
Description: Vehicle Gel
Study: NCT01581684

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Solution for oral administration