TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)
Brief Summary: The objective of this randomized, double blind, sham-controlled study is to demonstrate the safety and effectiveness of the Alair System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting β2-agonists.

The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from the 6-, 9-, and 12-month follow-up visits.

All other outcome measures assessed at 12 months post-treatment.

This will be a multicenter, randomized, double-blind, sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA).

A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 2:1 (two Alair Group Subjects for every one Control Group Subject).


Options:
A: Arm Label: Alair Group; Type: EXPERIMENTAL; Interventions: Procedure: Bronchial thermoplasty with the Alair System | Arm Label: Control Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Conventional therapy with ICS+LABA | Intervention Type: PROCEDURE; Name: Bronchial thermoplasty with the Alair System; Assigned to Arm(s): Alair Group | Intervention Type: DRUG; Name: Conventional therapy with ICS+LABA; Assigned to Arm(s): Control Group
B: Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Procedure: Bronchial Thermoplasty with the Alair System | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Control | Intervention Type: PROCEDURE; Name: Bronchial Thermoplasty with the Alair System; Assigned to Arm(s): Treatment | Intervention Type: DRUG; Name: Control; Assigned to Arm(s): Control
C: Arm Label: Alair Treatment; Type: N/A; Interventions: Device: Bronchial thermoplasty with the Alair System | Intervention Type: DEVICE; Name: Bronchial thermoplasty with the Alair System; Assigned to Arm(s): Alair Treatment
D: Arm Label: Alair; Type: EXPERIMENTAL; Interventions: Device: Alair System | Arm Label: Sham; Type: SHAM_COMPARATOR; Interventions: Device: Alair System | Intervention Type: DEVICE; Name: Alair System; Assigned to Arm(s): Alair | Intervention Type: DEVICE; Name: Alair System; Assigned to Arm(s): Sham

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)
Brief Summary: The objective of this randomized, double blind, sham-controlled study is to demonstrate the safety and effectiveness of the Alair System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting β2-agonists.

The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from the 6-, 9-, and 12-month follow-up visits.

All other outcome measures assessed at 12 months post-treatment.

This will be a multicenter, randomized, double-blind, sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA).

A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 2:1 (two Alair Group Subjects for every one Control Group Subject).


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: lebrikizumab (MILR1444A) | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: lebrikizumab (MILR1444A); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2
B: Arm Label: MEDI528 50 mg; Type: EXPERIMENTAL; Interventions: Biological: MEDI528 50 mg | Arm Label: PLACEBO; Type: PLACEBO_COMPARATOR; Interventions: Other: PLACEBO | Intervention Type: BIOLOGICAL; Name: MEDI528 50 mg; Assigned to Arm(s): MEDI528 50 mg | Intervention Type: OTHER; Name: PLACEBO; Assigned to Arm(s): PLACEBO
C: Arm Label: Alair; Type: EXPERIMENTAL; Interventions: Device: Alair System | Arm Label: Sham; Type: SHAM_COMPARATOR; Interventions: Device: Alair System | Intervention Type: DEVICE; Name: Alair System; Assigned to Arm(s): Alair | Intervention Type: DEVICE; Name: Alair System; Assigned to Arm(s): Sham
D: Arm Label: Omalizumab; Type: EXPERIMENTAL; Interventions: Drug: Omalizumab, Drug: Fluticasone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Fluticasone | Intervention Type: DRUG; Name: Omalizumab; Assigned to Arm(s): Omalizumab | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Fluticasone; Assigned to Arm(s): Omalizumab, Placebo

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized, Open, Parallel Group Study for the Evaluation of an Oral Dose of 100 mg Thalidomide and Subsequent Dose Escalation of 400 mg Thalidomide in Combination With Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
Brief Summary: Neuroinflammation has recently emerged as a significant contributor to motor neuron damage. ALS tissue is characterized by inflammatory changes that are observed in both sporadic and familial ALS and in the ALS superoxide dismutase 1 (SOD1) transgenic mouse model. They include an accumulation of large numbers of activated microglia and astrocytes.

Proinflammatory cytokines, such as tumor necrosis factor (TNF-), are robustly upregulated in ALS. The receptor for tumor necrosis factor- (TNF-R1) is elevated at late presymptomatic as well as symptomatic phases of disease. TNF acts as a principal driver for neuroinflammation in ALS, while several co-stimulating cytokines and chemokines act to potentiate the TNF effects \[4-6\].

We propose an investigational therapy of ALS with oral administration of thalidomide. The rationale for this study is based on the anti-inflammatory properties of thalidomide through the modulation of inflammatory cytokines such as TNF. The primary aim of the trial is to determine whether treatment with thalidomide is safe and well tolerated in conjunction with riluzole and whether patients with ALS can tolerate daily doses of up to 400 mg. The trial is designed as feasibility study in planning for a larger phase IIb/III trial of efficacy.


Options:
A: Intervention Type: DRUG; Name: Sodium Valproate; Assigned to Arm(s): N/A
B: Intervention Type: DRUG; Name: Thalidomide (drug); Assigned to Arm(s): N/A
C: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Real rTMS of the brain | Arm Label: B; Type: SHAM_COMPARATOR; Interventions: Procedure: Sham rTMS of the brain | Intervention Type: PROCEDURE; Name: Real rTMS of the brain; Assigned to Arm(s): A | Intervention Type: PROCEDURE; Name: Sham rTMS of the brain; Assigned to Arm(s): B
D: Intervention Type: DRUG; Name: minocycline; Assigned to Arm(s): N/A

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy
Brief Summary: The primary objective of this study is to compare the safety and effectiveness of the Cordis Nitinol Carotid Stent and Delivery Systems (5.5 F and 7 F) with the ANGIOGUARD XP distal protective device to CEA in the treatment of carotid artery disease in patients at increased risk for surgery.


Options:
A: Arm Label: Carotid Artery Endarterectomy (CEA); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Carotid Endarterectomy (CEA) | Arm Label: Carotid Artery Stenting (CAS); Type: ACTIVE_COMPARATOR; Interventions: Device: Carotid Artery Stenting (CAS) | Intervention Type: PROCEDURE; Name: Carotid Endarterectomy (CEA); Assigned to Arm(s): Carotid Artery Endarterectomy (CEA) | Intervention Type: DEVICE; Name: Carotid Artery Stenting (CAS); Assigned to Arm(s): Carotid Artery Stenting (CAS)
B: Intervention Type: DEVICE; Name: Cordis Nitinol Stent; Assigned to Arm(s): N/A | Intervention Type: DEVICE; Name: PRECISE tapered stent; Assigned to Arm(s): N/A | Intervention Type: DEVICE; Name: ANGIOGUARD XP Emboli Capture Guidewire (ECGW); Assigned to Arm(s): N/A
C: N/A
D: Arm Label: MICHI NPS+f; Type: EXPERIMENTAL; Interventions: Device: MICHI NPS+f | Intervention Type: DEVICE; Name: MICHI NPS+f; Assigned to Arm(s): MICHI NPS+f

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy
Brief Summary: The primary objective of this study is to compare the safety and effectiveness of the Cordis Nitinol Carotid Stent and Delivery Systems (5.5 F and 7 F) with the ANGIOGUARD XP distal protective device to CEA in the treatment of carotid artery disease in patients at increased risk for surgery.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Device: Carotid angioplasty and stenting with cerebral protection | Intervention Type: DEVICE; Name: Carotid angioplasty and stenting with cerebral protection; Assigned to Arm(s): 1
B: Arm Label: CEA with sonolysis; Type: EXPERIMENTAL; Interventions: Procedure: sonolysis, Procedure: endarterectomy | Arm Label: CEA without sonolysis; Type: PLACEBO_COMPARATOR; Interventions: Procedure: endarterectomy | Arm Label: carotid stenting with sonolysis; Type: EXPERIMENTAL; Interventions: Procedure: sonolysis, Procedure: carotid stenting | Arm Label: carotid stenting without sonolysis; Type: PLACEBO_COMPARATOR; Interventions: Procedure: carotid stenting | Intervention Type: PROCEDURE; Name: sonolysis; Assigned to Arm(s): CEA with sonolysis, carotid stenting with sonolysis | Intervention Type: PROCEDURE; Name: endarterectomy; Assigned to Arm(s): CEA with sonolysis, CEA without sonolysis | Intervention Type: PROCEDURE; Name: carotid stenting; Assigned to Arm(s): carotid stenting with sonolysis, carotid stenting without sonolysis
C: Intervention Type: DEVICE; Name: Cordis Nitinol Stent; Assigned to Arm(s): N/A | Intervention Type: DEVICE; Name: PRECISE tapered stent; Assigned to Arm(s): N/A | Intervention Type: DEVICE; Name: ANGIOGUARD XP Emboli Capture Guidewire (ECGW); Assigned to Arm(s): N/A
D: Arm Label: Carotid Endarterectomy (CEA); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Carotid endarterectomy (CEA) | Arm Label: Carotid Stenting (CAS); Type: ACTIVE_COMPARATOR; Interventions: Device: Carotid Stenting (CAS) | Arm Label: Intensive Medical Management - no CEA; Type: EXPERIMENTAL; Interventions: Other: Intensive Medical Management - no CEA | Arm Label: Intensive Medical Management - no CAS; Type: EXPERIMENTAL; Interventions: Other: Intensive Medical Management - no CAS | Intervention Type: PROCEDURE; Name: Carotid endarterectomy (CEA); Assigned to Arm(s): Carotid Endarterectomy (CEA) | Intervention Type: DEVICE; Name: Carotid Stenting (CAS); Assigned to Arm(s): Carotid Stenting (CAS) | Intervention Type: OTHER; Name: Intensive Medical Management - no CEA; Assigned to Arm(s): Intensive Medical Management - no CEA | Intervention Type: OTHER; Name: Intensive Medical Management - no CAS; Assigned to Arm(s): Intensive Medical Management - no CAS

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of a 6-Months Physical Conditioning Program on Health Status and Physical Activity in Youths and Young Adults With Cystic Fibrosis - MUKOTRAIN
Brief Summary: The purpose of this randomized, controlled trial was to determine whether a (and if so which) physical conditioning program is effective to improve health status, physical activity, and quality of life in patients with cystic fibrosis. A positive effect of physical conditioning was expected.


Options:
A: Arm Label: MOBILE-A; Type: EXPERIMENTAL; Interventions: Behavioral: Coached exercise persistence intervention | Arm Label: MOBILE-B; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Self-Monitored exercise persistence intervention | Intervention Type: BEHAVIORAL; Name: Coached exercise persistence intervention; Assigned to Arm(s): MOBILE-A | Intervention Type: BEHAVIORAL; Name: Self-Monitored exercise persistence intervention; Assigned to Arm(s): MOBILE-B
B: Arm Label: Placebo (pooled two times a day [BID]/three times a day [TID]); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo two times a day (BID)/three times a day (TID) | Arm Label: AZLI (pooled two times a day [BID]/three times a day [TID]); Type: EXPERIMENTAL; Interventions: Drug: AZLI 75 mg two times a day (BID)/three times a day (TID) | Intervention Type: DRUG; Name: AZLI 75 mg two times a day (BID)/three times a day (TID); Assigned to Arm(s): AZLI (pooled two times a day [BID]/three times a day [TID]) | Intervention Type: DRUG; Name: Placebo two times a day (BID)/three times a day (TID); Assigned to Arm(s): Placebo (pooled two times a day [BID]/three times a day [TID])
C: Intervention Type: BEHAVIORAL; Name: Supervised aerobic training; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Supervised strength training; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Unsupervised training; Assigned to Arm(s): N/A
D: Arm Label: website and pedometer; Type: EXPERIMENTAL; Interventions: Behavioral: website and pedometer | Intervention Type: BEHAVIORAL; Name: website and pedometer; Assigned to Arm(s): website and pedometer

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of a 6-Months Physical Conditioning Program on Health Status and Physical Activity in Youths and Young Adults With Cystic Fibrosis - MUKOTRAIN
Brief Summary: The purpose of this randomized, controlled trial was to determine whether a (and if so which) physical conditioning program is effective to improve health status, physical activity, and quality of life in patients with cystic fibrosis. A positive effect of physical conditioning was expected.


Options:
A: Arm Label: Cycling in combination with Flutter® therapy; Type: EXPERIMENTAL; Interventions: Device: Flutter® | Arm Label: Cycling without Flutter® therapy; Type: ACTIVE_COMPARATOR; Interventions: Device: No Flutter® | Intervention Type: DEVICE; Name: Flutter®; Assigned to Arm(s): Cycling in combination with Flutter® therapy | Intervention Type: DEVICE; Name: No Flutter®; Assigned to Arm(s): Cycling without Flutter® therapy
B: Arm Label: High Intensity Interval Training; Type: EXPERIMENTAL; Interventions: Other: Educational intervention, Other: Aerobic exercise | Arm Label: Control Group; Type: ACTIVE_COMPARATOR; Interventions: Other: Educational intervention | Intervention Type: OTHER; Name: Educational intervention; Assigned to Arm(s): Control Group, High Intensity Interval Training | Intervention Type: OTHER; Name: Aerobic exercise; Assigned to Arm(s): High Intensity Interval Training
C: Intervention Type: BEHAVIORAL; Name: Supervised aerobic training; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Supervised strength training; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Unsupervised training; Assigned to Arm(s): N/A
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: LUM 600 mg qd/IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination, Drug: Ivacaftor | Arm Label: LUM 400 mg q12h/ IVA 250 mg q12h; Type: EXPERIMENTAL; Interventions: Drug: Lumacaftor Plus Ivacaftor Combination | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Lumacaftor Plus Ivacaftor Combination; Assigned to Arm(s): LUM 400 mg q12h/ IVA 250 mg q12h, LUM 600 mg qd/IVA 250 mg q12h | Intervention Type: DRUG; Name: Ivacaftor; Assigned to Arm(s): LUM 600 mg qd/IVA 250 mg q12h

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of a 6-Months Physical Conditioning Program on Health Status and Physical Activity in Youths and Young Adults With Cystic Fibrosis - MUKOTRAIN
Brief Summary: The purpose of this randomized, controlled trial was to determine whether a (and if so which) physical conditioning program is effective to improve health status, physical activity, and quality of life in patients with cystic fibrosis. A positive effect of physical conditioning was expected.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Electrostimulation programme: using a cycloergometer | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Usual sport activity | Intervention Type: BEHAVIORAL; Name: Electrostimulation programme: using a cycloergometer; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Usual sport activity; Assigned to Arm(s): 2
B: Arm Label: Exercise; Type: OTHER; Interventions: Other: Exercise | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Exercise; Assigned to Arm(s): Exercise
C: Arm Label: 1. Exercise testing and self drainage session; Type: EXPERIMENTAL; Interventions: Procedure: Chest physiotherapy | Arm Label: 2. Chest physiotherapy (CP) session; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Chest physiotherapy | Intervention Type: PROCEDURE; Name: Chest physiotherapy; Assigned to Arm(s): 1. Exercise testing and self drainage session, 2. Chest physiotherapy (CP) session
D: Intervention Type: BEHAVIORAL; Name: Supervised aerobic training; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Supervised strength training; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Unsupervised training; Assigned to Arm(s): N/A

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Eicosapentaenoic Acid (EPA) on Major Cardiovascular Events in Hypercholesterolemic Patients: the Japan EPA Lipid Intervention Study (JELIS)
Brief Summary: The purpose of this study was to test the hypothesis that the long-term use of highly (\>98%) purified EPA, in addition to HMG-CoA reductase inhibitor (statin), would be more effective than statin alone in preventing cardiovascular events in Japanese patients with hypercholesterolemia.


Options:
A: Arm Label: 1 Epanova; Type: EXPERIMENTAL; Interventions: Drug: Epanova | Arm Label: 2 Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Epanova | Intervention Type: DRUG; Name: Epanova; Assigned to Arm(s): 1 Epanova, 2 Placebo
B: Arm Label: N-3 PUFA; Type: EXPERIMENTAL; Interventions: Drug: N-3 Polyunsaturated Fatty Acids | Arm Label: Olive oil; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo: Olive oil | Intervention Type: DRUG; Name: N-3 Polyunsaturated Fatty Acids; Assigned to Arm(s): N-3 PUFA | Intervention Type: DRUG; Name: Placebo: Olive oil; Assigned to Arm(s): Olive oil
C: Intervention Type: DRUG; Name: Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM); Assigned to Arm(s): N/A
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Zodin (drug) | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Olive oil (placebo) | Intervention Type: DRUG; Name: Zodin (drug); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Olive oil (placebo); Assigned to Arm(s): 2

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Eicosapentaenoic Acid (EPA) on Major Cardiovascular Events in Hypercholesterolemic Patients: the Japan EPA Lipid Intervention Study (JELIS)
Brief Summary: The purpose of this study was to test the hypothesis that the long-term use of highly (\>98%) purified EPA, in addition to HMG-CoA reductase inhibitor (statin), would be more effective than statin alone in preventing cardiovascular events in Japanese patients with hypercholesterolemia.


Options:
A: Arm Label: Lower fat diet; Type: EXPERIMENTAL; Interventions: Behavioral: Weight loss | Arm Label: Lower carbohydrate diet; Type: EXPERIMENTAL; Interventions: Behavioral: Weight loss | Arm Label: Walnut-rich diet; Type: EXPERIMENTAL; Interventions: Behavioral: Weight loss | Intervention Type: BEHAVIORAL; Name: Weight loss; Assigned to Arm(s): Lower carbohydrate diet, Lower fat diet, Walnut-rich diet
B: Intervention Type: DRUG; Name: Epanova™ (Omega-3 Free Fatty Acids); Assigned to Arm(s): N/A
C: Intervention Type: DRUG; Name: Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM); Assigned to Arm(s): N/A
D: Arm Label: 1.; Type: EXPERIMENTAL; Interventions: Drug: DHA (Docosahexaenoic Acid) | Arm Label: 2.; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: DHA (Docosahexaenoic Acid); Assigned to Arm(s): 1. | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2.

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Eicosapentaenoic Acid (EPA) on Major Cardiovascular Events in Hypercholesterolemic Patients: the Japan EPA Lipid Intervention Study (JELIS)
Brief Summary: The purpose of this study was to test the hypothesis that the long-term use of highly (\>98%) purified EPA, in addition to HMG-CoA reductase inhibitor (statin), would be more effective than statin alone in preventing cardiovascular events in Japanese patients with hypercholesterolemia.


Options:
A: Intervention Type: DRUG; Name: Eicosapentaenoic acid ethyl ester(EPADEL Capsule 300 TM); Assigned to Arm(s): N/A
B: 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
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Omega 3 (n-3 PUFA) | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Omega 3 (n-3 PUFA); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2
D: Arm Label: OMEGA-3; Type: ACTIVE_COMPARATOR; Interventions: Drug: OMEGA-3 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo soybean oil | Intervention Type: DRUG; Name: OMEGA-3; Assigned to Arm(s): OMEGA-3 | Intervention Type: DRUG; Name: Placebo soybean oil; Assigned to Arm(s): Placebo

Answer: A