TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Pilot Study To Evaluate Various Methodologies For Assessing The Treatment Of Low Back Pain
Brief Summary: The study is designed to assess methods used in clinical research.


Options:
A: Arm Label: ibuprofen + caffeine; Type: EXPERIMENTAL; Interventions: Drug: ibuprofen, Drug: caffeine | Arm Label: ibuprofen; Type: ACTIVE_COMPARATOR; Interventions: Drug: ibuprofen | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: ibuprofen; Assigned to Arm(s): ibuprofen, ibuprofen + caffeine | Intervention Type: DRUG; Name: caffeine; Assigned to Arm(s): ibuprofen + caffeine | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo
B: Arm Label: Opioid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Naproxen, Drug: Oxycodone/ acetaminophen | Arm Label: Skeletal muscle relaxant; Type: ACTIVE_COMPARATOR; Interventions: Drug: Naproxen, Drug: Cyclobenzaprine | Arm Label: Naproxen alone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Naproxen | Intervention Type: DRUG; Name: Naproxen; Assigned to Arm(s): Naproxen alone, Opioid, Skeletal muscle relaxant | Intervention Type: DRUG; Name: Cyclobenzaprine; Assigned to Arm(s): Skeletal muscle relaxant | Intervention Type: DRUG; Name: Oxycodone/ acetaminophen; Assigned to Arm(s): Opioid
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Device: Heat Device | Arm Label: 2; Type: SHAM_COMPARATOR; Interventions: Device: Sham Device | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: marketed analgesic | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DEVICE; Name: Heat Device; Assigned to Arm(s): 1 | Intervention Type: DEVICE; Name: Sham Device; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: marketed analgesic; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 4
D: Arm Label: acupuncture; Type: EXPERIMENTAL; Interventions: Other: acupuncture, injection | Arm Label: injections of diclofenac; Type: ACTIVE_COMPARATOR; Interventions: Other: acupuncture, injection | Intervention Type: OTHER; Name: acupuncture, injection; Assigned to Arm(s): acupuncture, injections of diclofenac

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Metformin Treatment Before IVF in Women With Ultrasound Evidence of Polycystic Ovaries; a Prospective, Randomised, Double Blind, Placebo Study
Brief Summary: The aim of study was to investigate whether pre-treatment with metformin before and during IVF increases the live birth rate compared to placebo in women with sonographic evidence of polycystic ovaries (PCO), but without any clinical manifestations of polycystic ovary syndrome (PCOS).


Options:
A: Arm Label: Metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin | Arm Label: Sugar pill; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Metformin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Sugar pill
B: Arm Label: M: Metformin P: Placebo; Type: EXPERIMENTAL; Interventions: Drug: Metformin / Placebo treatment for 4 months | Intervention Type: DRUG; Name: Metformin / Placebo treatment for 4 months; Assigned to Arm(s): M: Metformin P: Placebo
C: Arm Label: Experimental group; Type: EXPERIMENTAL; Interventions: Drug: Metformin | Arm Label: Control group; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo administration | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Experimental group | Intervention Type: DRUG; Name: Placebo administration; Assigned to Arm(s): Control group
D: Arm Label: Metformin-treated group; Type: EXPERIMENTAL; Interventions: Drug: Metformin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Metformin-treated group | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Preventing Excessive Weight Gain by Reducing Carbonated Beverage and Sugar Consumption and Increasing Physical Activity Among Public School Adolescents From the Metropolitan Area of Rio de Janeiro
Brief Summary: The main objective is to evaluate the effect on BMI of a school-based program that discourages the consumption of all sweetened beverages, encourages the reduction in sugar intake, and encourages the increase in physical activity among adolescents and their families from a low socioeconomic area.


Options:
A: Arm Label: reducing beverages and sugar and increase physical activity; Type: EXPERIMENTAL; Interventions: Behavioral: lifestyle | Arm Label: control -no intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: lifestyle; Assigned to Arm(s): reducing beverages and sugar and increase physical activity
B: Arm Label: School based intervention; Type: EXPERIMENTAL; Interventions: Behavioral: integrated program of nutrition, activity, behavior, and promotion | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: integrated program of nutrition, activity, behavior, and promotion; Assigned to Arm(s): School based intervention
C: Arm Label: No calorie beverages; Type: EXPERIMENTAL; Interventions: Behavioral: 2 no calorie beverages per day | Arm Label: Water; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: 2 water beverages per day | Intervention Type: BEHAVIORAL; Name: 2 no calorie beverages per day; Assigned to Arm(s): No calorie beverages | Intervention Type: BEHAVIORAL; Name: 2 water beverages per day; Assigned to Arm(s): Water
D: Arm Label: Water; Type: EXPERIMENTAL; Interventions: Other: Water | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Other: Education | Intervention Type: OTHER; Name: Water; Assigned to Arm(s): Water | Intervention Type: OTHER; Name: Education; Assigned to Arm(s): Control

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Preventing Excessive Weight Gain by Reducing Carbonated Beverage and Sugar Consumption and Increasing Physical Activity Among Public School Adolescents From the Metropolitan Area of Rio de Janeiro
Brief Summary: The main objective is to evaluate the effect on BMI of a school-based program that discourages the consumption of all sweetened beverages, encourages the reduction in sugar intake, and encourages the increase in physical activity among adolescents and their families from a low socioeconomic area.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: Experimental | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Experimental; Assigned to Arm(s): 1
B: Arm Label: Tools for Teen Moms Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: Tools for Teen Moms | Arm Label: MIHP standard care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Tools for Teen Moms; Assigned to Arm(s): Tools for Teen Moms Intervention Group
C: Arm Label: reducing beverages and sugar and increase physical activity; Type: EXPERIMENTAL; Interventions: Behavioral: lifestyle | Arm Label: control -no intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: lifestyle; Assigned to Arm(s): reducing beverages and sugar and increase physical activity
D: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: School children and adolescents as health experts | Arm Label: B; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: School children and adolescents as health experts; Assigned to Arm(s): A

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Lactobacillus Reuteri DSM 17938 in the Prevention of Nosocomial Diarrhea in Children. Randomized Double-blind Placebo Controlled Trial
Brief Summary: Nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. In children, it is commonly caused by enteric pathogens, especially rotavirus. The reported incidence ranges from 4.5 to 22.6 episodes per 100 admissions. Nosocomial diarrhea may prolong the hospital stay and increase medical costs. One of the potential strategies for the prevention of nosocomial infections is the use of probiotics. The number of studies have shown the efficacy of Lactobacillus reuteri (DSM 17938) in the treatment of acute diarrhea. However, there are no data on the efficacy of L. reuteri in the prevention of nosocomial diarrhea. The investigators, therefore, plan to perform the study with the aim of evaluating the role of Lactobacillus reuteri DSM 17938 administration in the prevention of nosocomial gastroenteritis in a pediatric hospital setting.


Options:
A: Arm Label: Probiotics; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Probiotic capsules | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo capsules | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotic capsules; Assigned to Arm(s): Probiotics | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo capsules; Assigned to Arm(s): Placebo
B: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Lactobacillus GG | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Lactobacillus GG; Assigned to Arm(s): 1 | Intervention Type: DIETARY_SUPPLEMENT; Name: placebo; Assigned to Arm(s): 2
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: Kefir; Type: EXPERIMENTAL; Interventions: Other: Kefir | Intervention Type: OTHER; Name: Kefir; Assigned to Arm(s): Kefir | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
D: Intervention Type: DIETARY_SUPPLEMENT; Name: Lactobacillus reuteri (DSM 17938); Assigned to Arm(s): N/A

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: ThrombElastoGraphic Haemostatic Status and Antiplatelet Therapy After Coronary Artery Bypass Graft Surgery(TEG-CABG Trial):Does Intensified Postoperative Antiplatelet Therapy in Preoperatively Identified Hypercoagulable Patients Improve Outcome After CABG Surgery
Brief Summary: The purpose of this study is to determine whether adding clopidogrel to aspirin after coronary bypass operation (CABG) improves graft patency, in patients that have preoperatively increased platelet activity(hypercoagulable) and therefore greater risk of graft occlusion( thrombosis).


Options:
A: Arm Label: coronary artery disease; Type: N/A; Interventions: N/A
B: Arm Label: POC algorithm; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Point-of-Care versus conventional coagulation management | Arm Label: conventional algorithm; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Point-of-Care versus conventional coagulation management | Intervention Type: PROCEDURE; Name: Point-of-Care versus conventional coagulation management; Assigned to Arm(s): POC algorithm, conventional algorithm
C: Arm Label: Fibrinogen if FibTEM < 8 mm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Human fibrinogen concentrate | Arm Label: Fibrinogen if FibTEM < 13 mm; Type: EXPERIMENTAL; Interventions: Drug: Human fibrinogen concentrate | Intervention Type: DRUG; Name: Human fibrinogen concentrate; Assigned to Arm(s): Fibrinogen if FibTEM < 13 mm, Fibrinogen if FibTEM < 8 mm
D: Arm Label: Clopidogrel+Aspirin, hypercoagulabel; Type: EXPERIMENTAL; Interventions: Drug: Clopidogrel+acetylsalicylic acid | Arm Label: Aspirin,hypercoagulabel control; Type: ACTIVE_COMPARATOR; Interventions: Drug: acetylsalicylic acid | Intervention Type: DRUG; Name: Clopidogrel+acetylsalicylic acid; Assigned to Arm(s): Clopidogrel+Aspirin, hypercoagulabel | Intervention Type: DRUG; Name: acetylsalicylic acid; Assigned to Arm(s): Aspirin,hypercoagulabel control

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised Control Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder
Brief Summary: The purpose of this study is determine whether a specialised mood disorder service, which offers tailored psychological and pharmacological treatment, is more effective in the treatment of chronic unipolar depressive disorder then treatment as usual.


Options:
A: Arm Label: Cognitive therapy plus medications; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Therapy, Drug: Medications | Arm Label: Medications alone; Type: EXPERIMENTAL; Interventions: Drug: Medications | Intervention Type: BEHAVIORAL; Name: Cognitive Therapy; Assigned to Arm(s): Cognitive therapy plus medications | Intervention Type: DRUG; Name: Medications; Assigned to Arm(s): Cognitive therapy plus medications, Medications alone
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Contingency Management | Arm Label: 2; Type: OTHER; Interventions: Behavioral: Non Contingent Control Condition | Intervention Type: BEHAVIORAL; Name: Contingency Management; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Non Contingent Control Condition; Assigned to Arm(s): 2
C: Intervention Type: BEHAVIORAL; Name: Control with depression course (CWD); Assigned to Arm(s): N/A
D: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Specialist Mood Disorders Team | Arm Label: Treatment as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Specialist Mood Disorders Team; Assigned to Arm(s): Intervention

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase IIa, Randomized, Single-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of 28-day Repeat Oral Doses of GSK1278863A in Anemic Pre-dialysis and Hemodialysis-dependent Patients
Brief Summary: The purpose of this study is to characterize the safety and efficacy of repeat doses of compound 1278863A in subjects with anemia.


Options:
A: Arm Label: BAY85-3934 (25mg); Type: EXPERIMENTAL; Interventions: Drug: BAY85-3934 | Arm Label: BAY85-3934 (50mg); Type: EXPERIMENTAL; Interventions: Drug: BAY85-3934 | Arm Label: BAY85-3934 (75mg); Type: EXPERIMENTAL; Interventions: Drug: BAY85-3934 | Arm Label: Darbepoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Biological: Darbepoetin alfa | Intervention Type: DRUG; Name: BAY85-3934; Assigned to Arm(s): BAY85-3934 (25mg), BAY85-3934 (50mg), BAY85-3934 (75mg) | Intervention Type: BIOLOGICAL; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa
B: Arm Label: Group 1; Type: EXPERIMENTAL; Interventions: Drug: 1278863A | Arm Label: Group 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: 1278863A; Assigned to Arm(s): Group 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Group 2
C: Arm Label: GSK1278863 4 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 6 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 8 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 10 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 12 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: rhEPO | Intervention Type: DRUG; Name: GSK1278863; Assigned to Arm(s): GSK1278863 10 mg, GSK1278863 12 mg, GSK1278863 4 mg, GSK1278863 6 mg, GSK1278863 8 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Control | Intervention Type: DRUG; Name: rhEPO; Assigned to Arm(s): Control
D: Arm Label: Vadadustat; Type: EXPERIMENTAL; Interventions: Drug: Vadadustat | Arm Label: Darbepoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin alfa | Intervention Type: DRUG; Name: Vadadustat; Assigned to Arm(s): Vadadustat | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: ACtive Care After Transplantation, a Lifestyle Intervention in Renal Transplant Recipients
Brief Summary: The aim of the present study is to compare the outcomes of standard care to the effects of exercise alone, and exercise combined with nutrition counseling, on post-transplantation weight gain and quality of life in renal transplant recipients (RTR). The primary outcome is subdomain physical functioning of quality of life, (SF-36 PFS).

Secondary outcomes include other evaluations of quality of life (SF-36, KDQOL-SF, EQ-5D), objective measures of physical functioning (aerobic capacity and muscle strength), level of physical activity, gain in adiposity (body fat percentage by bio-electrical impedance assessment, BMI, waist circumference), and cardiometabolic risk factors (blood pressure, lipids, glucose metabolism). Additionally it is planned to study data on renal function, medical history, medication, psychological factors (motivation, kinesiophobia, coping style), nutrition knowledge, nutrition intake, nutrition status, fatigue, work participation, process evaluation and cost-effectiveness.


Options:
A: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Exercise; Type: EXPERIMENTAL; Interventions: Other: Exercise | Intervention Type: OTHER; Name: Exercise; Assigned to Arm(s): Exercise
B: Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Exercise intervention; Type: EXPERIMENTAL; Interventions: Other: Exercise intervention | Arm Label: Exercise intervention and dietary advice; Type: EXPERIMENTAL; Interventions: Other: Exercise intervention, Other: Exercise intervention and dietary advice | Intervention Type: OTHER; Name: Exercise intervention; Assigned to Arm(s): Exercise intervention, Exercise intervention and dietary advice | Intervention Type: OTHER; Name: Exercise intervention and dietary advice; Assigned to Arm(s): Exercise intervention and dietary advice
C: Arm Label: control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: weight reduction; Type: EXPERIMENTAL; Interventions: Behavioral: weight reduction | Intervention Type: BEHAVIORAL; Name: weight reduction; Assigned to Arm(s): weight reduction
D: Intervention Type: BEHAVIORAL; Name: dietary intervention; Assigned to Arm(s): N/A

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomised, Double-blind, Placebo-controlled Trial of the Effect of the Combination of Imipramine and Pregabalin for the Treatment of Painful Polyneuropathy
Brief Summary: Polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the single compounds alone.

This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include 60 patients and the treatment outcome will be pain intensity as measured by numeric rating scales.


Options:
A: Arm Label: ABT-639; Type: EXPERIMENTAL; Interventions: Drug: ABT-639 | Arm Label: pregabalin; Type: ACTIVE_COMPARATOR; Interventions: Drug: pregabalin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: ABT-639; Assigned to Arm(s): ABT-639 | Intervention Type: DRUG; Name: pregabalin; Assigned to Arm(s): pregabalin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Imipramine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Imipramine | Arm Label: Pregabalin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Pregabalin | Arm Label: Imipramine plus pregabalin; Type: EXPERIMENTAL; Interventions: Drug: Imipramine, pregabalin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Imipramine; Assigned to Arm(s): Imipramine | Intervention Type: DRUG; Name: Pregabalin; Assigned to Arm(s): Pregabalin | Intervention Type: DRUG; Name: Imipramine, pregabalin; Assigned to Arm(s): Imipramine plus pregabalin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Pregablain CR tablet 82.5 to 660mg; Type: EXPERIMENTAL; Interventions: Drug: Pregabalin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Pregabalin; Assigned to Arm(s): Pregablain CR tablet 82.5 to 660mg | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo
D: Intervention Type: DRUG; Name: pregabalin; Assigned to Arm(s): N/A

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Evaluation of the Effect of Two Doses of AMR101 (Ethyl Icosapentate) on Fasting Serum Triglyceride Levels in Patients With Persistent High Triglyceride Levels (≥ 200 mg/dL and < 500 mg/dL) Despite Statin Therapy
Brief Summary: The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and \< 500 mg/dL.


Options:
A: Arm Label: Insulin glargine + omega-3 polyunsaturated fatty acids; Type: EXPERIMENTAL; Interventions: Drug: insulin glargine (HOE901), Drug: omega-3 polyunsaturated fatty acids (PUFA), Device: reusable pen device for insulin injection | Arm Label: Insulin glargine + placebo; Type: EXPERIMENTAL; Interventions: Drug: insulin glargine (HOE901), Drug: placebo, Device: reusable pen device for insulin injection | Arm Label: Standard care + omega-3 polyunsaturated fatty acids; Type: EXPERIMENTAL; Interventions: Drug: omega-3 polyunsaturated fatty acids (PUFA) | Arm Label: Standard care + placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: insulin glargine (HOE901); Assigned to Arm(s): Insulin glargine + omega-3 polyunsaturated fatty acids, Insulin glargine + placebo | Intervention Type: DRUG; Name: omega-3 polyunsaturated fatty acids (PUFA); Assigned to Arm(s): Insulin glargine + omega-3 polyunsaturated fatty acids, Standard care + omega-3 polyunsaturated fatty acids | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Insulin glargine + placebo, Standard care + placebo | Intervention Type: DEVICE; Name: reusable pen device for insulin injection; Assigned to Arm(s): Insulin glargine + omega-3 polyunsaturated fatty acids, Insulin glargine + placebo
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: AMR101 (ethyl icosapentate) - 2 g/day; Type: EXPERIMENTAL; Interventions: Drug: AMR101 (ethyl icosapentate) - 2 g/day | Arm Label: AMR101 (ethyl icosapentate) - 4 g/day; Type: EXPERIMENTAL; Interventions: Drug: AMR101 (ethyl icosapentate) - 4 g/day | Intervention Type: DRUG; Name: AMR101 (ethyl icosapentate) - 4 g/day; Assigned to Arm(s): AMR101 (ethyl icosapentate) - 4 g/day | Intervention Type: DRUG; Name: AMR101 (ethyl icosapentate) - 2 g/day; Assigned to Arm(s): AMR101 (ethyl icosapentate) - 2 g/day | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Intervention Type: DRUG; Name: Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM); Assigned to Arm(s): N/A
D: Intervention Type: PROCEDURE; Name: Supplementation with fish oil versus placebo; Assigned to Arm(s): N/A

Answer: B