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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_634 |
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This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms beyond 6 months and will measure the impact of withdrawal of laropiprant in patients following 20 weeks of stable maintenance therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERN/LRPT | Experimental | One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks |
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| ERN/LRPT then ERN | Experimental | One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks. |
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| Placebo | Placebo Comparator | One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ER niacin (+) laropiprant (ERN/LRPT) | Drug | One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period | Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme). The number of days/week was derived as: 7*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period). The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, >0 to 0.5, >0.5 to 1, >1 to 2, >2 to 3, and >3 days per week. | Week 21 to Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period | Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assesses the overall severity of the flushing experience (including redness, warmth, tingling, or itching) using a scale with response categories of None, Mild, Moderate, Severe, and Extreme. The categories were supplemented with numbers 0 to 10 to allow for greater precision within each category (None=0, Mild=1-3, Moderate=4-6, Severe=7-9, Extreme=10). The daily response was recorded in the morning, and reflected the symptoms experienced during the previous 24 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22683042 | Result | Maccubbin DL, Chen F, Anderson JW, Sirah W, McCrary Sisk C, Kher U, Olsson AG, Bays HE, Mitchel YB. Effectiveness and safety of laropiprant on niacin-induced flushing. Am J Cardiol. 2012 Sep 15;110(6):817-22. doi: 10.1016/j.amjcard.2012.05.009. Epub 2012 Jun 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ERN/LRPT | One 1g/20 mg tablet Extended -release niacin (+) laropiprant (ERN/LRPT) once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks |
| FG001 | ERN/LRPT Then ERN |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ER niacin (+) laropiprant (ERN/LRPT) | Drug | One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks. |
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| Extended-release niacin (ERN) | Drug | Two 1g tablets ERN (2g total) once daily for 12 weeks. |
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| Placebo to ERN/LRPT | Drug | One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks |
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| Week 21 to Week 32 |
One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
| FG002 | Placebo | One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ERN/LRPT | One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks |
| BG001 | ERN/LRPT Then ERN | One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks. |
| BG002 | Placebo | One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period | Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme). The number of days/week was derived as: 7*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period). The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, >0 to 0.5, >0.5 to 1, >1 to 2, >2 to 3, and >3 days per week. | Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32). | Posted | Number | Participants | Week 21 to Week 32 |
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| Secondary | Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period | Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assesses the overall severity of the flushing experience (including redness, warmth, tingling, or itching) using a scale with response categories of None, Mild, Moderate, Severe, and Extreme. The categories were supplemented with numbers 0 to 10 to allow for greater precision within each category (None=0, Mild=1-3, Moderate=4-6, Severe=7-9, Extreme=10). The daily response was recorded in the morning, and reflected the symptoms experienced during the previous 24 hours. | Analysis performed using the Full Analysis Set (FAS) population which included all randomized participants that did not have a withdrawal visit and/or did not have at least 1 GFSS score during the post-withdrawal period (Weeks 21 to 32). | Posted | Number | Participants | Week 21 to Week 32 |
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Of 1152 randomized participants, 1148 participants took at least one dose of study medication and were included in the analyses of safety.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ERN/LRPT | One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks | 17 | 461 | 136 | 461 | ||
| EG001 | ERN/LRPT Then ERN | One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks. | 34 | 455 | 162 | 455 | ||
| EG002 | Placebo | One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks. | 13 | 232 | 37 | 232 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
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| Angina unstable | Cardiac disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | Systematic Assessment |
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| Cerumen impaction | Ear and labyrinth disorders | Systematic Assessment |
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| Goitre | Endocrine disorders | Systematic Assessment |
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| Optic ischaemic neuropathy | Eye disorders | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
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| Device malfunction | General disorders | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Diverticulitis | Infections and infestations | Systematic Assessment |
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| H1N1 influenza | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Post procedural infection | Infections and infestations | Systematic Assessment |
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| Post procedural sepsis | Infections and infestations | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | Systematic Assessment |
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| Urosepsis | Infections and infestations | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Foreign body | Injury, poisoning and procedural complications | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post procedural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Traumatic brain injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Tendon disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Intraocular melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Tongue cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | Systematic Assessment |
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| Epileptic aura | Nervous system disorders | Systematic Assessment |
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| Haemorrhage intracranial | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
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| Alcoholism | Psychiatric disorders | Systematic Assessment |
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| Major depression | Psychiatric disorders | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Arteriosclerosis | Vascular disorders | Systematic Assessment |
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| Thrombophlebitis | Vascular disorders | Systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Flushing | Vascular disorders | Systematic Assessment |
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Publications derived from this study should include input from the investigator(s) and Sponsor personnel. Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or his/her colleagues may publish the results for their study site independently. The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C518174 | MK-0524 |
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| >=65 years |
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| Male |
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| >0.5 to ≤1 Days per week |
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| >1.0 to ≤2 Days per week |
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| >2 to ≤3 Days per week |
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| >3 Days per week |
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| Placebo |
One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks. |
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