Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease.
Brief Summary: The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI \< 150) in CD patients in whom remission, stable for at least three months and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP, methotrexate, 5-ASA or antibiotics.

Secondary objectives are to assess the:

efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of CD related medical visits in subjects with CD in remission

safety and tolerability of Epanova

ability of Epanova to maintain the quality of life of CD patients in remission


Options:
A: Arm Label: n-3 PUFAs; Type: ACTIVE_COMPARATOR; Interventions: Drug: n-3 PUFAs, Drug: RASS inhibitors and/or RAS blockers, Drug: Amiodarone | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: RASS inhibitors and/or RAS blockers, Drug: Amiodarone | Intervention Type: DRUG; Name: n-3 PUFAs; Assigned to Arm(s): n-3 PUFAs | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: RASS inhibitors and/or RAS blockers; Assigned to Arm(s): n-3 PUFAs, placebo | Intervention Type: DRUG; Name: Amiodarone; Assigned to Arm(s): n-3 PUFAs, placebo
B: Arm Label: Lutein/Zeaxanthin; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Lutein/zeaxanthin | Arm Label: DHA/EPA; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: DHA/EPA | Arm Label: Lutein/Zeaxanthin + DHA/EPA; Type: ACTIVE_COMPARATOR; Interventions: Drug: Lutein/zeaxanthin and DHA/EPA | Arm Label: Placebo/Control; Type: PLACEBO_COMPARATOR; Interventions: N/A | Intervention Type: DIETARY_SUPPLEMENT; Name: Lutein/zeaxanthin; Assigned to Arm(s): Lutein/Zeaxanthin | Intervention Type: DIETARY_SUPPLEMENT; Name: DHA/EPA; Assigned to Arm(s): DHA/EPA | Intervention Type: DRUG; Name: Lutein/zeaxanthin and DHA/EPA; Assigned to Arm(s): Lutein/Zeaxanthin + DHA/EPA
C: 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
D: 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

Answer: D