Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT01380093
Status:
COMPLETED
Last Update Posted:
2012-05-31
First Post:
2011-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}, {'id': 'C550436', 'term': 'morphine, naltrexone combination'}, {'id': 'D009271', 'term': 'Naltrexone'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009270', 'term': 'Naloxone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Naloxone (Naloxone Challenge Phase)', 'description': 'Naloxone hydrochloride 0.2 mg IV followed by additional 0.6 mg naloxone hydrochloride IV, each dose followed by an assessment for signs of withdrawal.', 'otherNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo (Drug Discrimination Phase)', 'description': 'Single dose of matching placebo solution orally on Day 1 or 2.', 'otherNumAtRisk': 58, 'otherNumAffected': 1, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Morphine (Drug Discrimination Phase)', 'description': 'Single dose of morphine sulfate 120 mg solution orally on Day 1 or 2.', 'otherNumAtRisk': 59, 'otherNumAffected': 51, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo (Treatment Phase)', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.', 'otherNumAtRisk': 36, 'otherNumAffected': 2, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'EMBEDA (Treatment Phase)', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.', 'otherNumAtRisk': 35, 'otherNumAffected': 10, 'seriousNumAtRisk': 35, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Morphine (Treatment Phase)', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.', 'otherNumAtRisk': 33, 'otherNumAffected': 27, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Bipolar Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Schizoaffective Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 33, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.3', 'spread': '4.41', 'groupId': 'OG000', 'lowerLimit': '83.6', 'upperLimit': '93.6'}, {'value': '100.3', 'spread': '12.29', 'groupId': 'OG001', 'lowerLimit': '95.5', 'upperLimit': '105.5'}, {'value': '124.7', 'spread': '22.70', 'groupId': 'OG002', 'lowerLimit': '120.4', 'upperLimit': '130.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.9', 'ciLowerLimit': '-31.7', 'ciUpperLimit': '-18.1', 'pValueComment': 'p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.', 'groupDescription': 'Least square (LS) mean and 95% confidence interval (CI) were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.9', 'ciLowerLimit': '5.1', 'ciUpperLimit': '18.6', 'pValueComment': 'p-value adjusted for multiple comparisons with Hochberg adjustment.', 'groupDescription': 'LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.8', 'ciLowerLimit': '30.0', 'ciUpperLimit': '43.6', 'pValueComment': 'p-value adjusted for multiple comparisons with Hochberg adjustment.', 'groupDescription': 'LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2).', 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose pharmacodynamic (PD) data from each period and did not have major protocol violations.'}, {'type': 'PRIMARY', 'title': 'Drug Liking: Peak Effect (Emax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '4.21', 'groupId': 'OG000', 'lowerLimit': '48.3', 'upperLimit': '55.1'}, {'value': '65.2', 'spread': '11.21', 'groupId': 'OG001', 'lowerLimit': '61.7', 'upperLimit': '68.6'}, {'value': '80.6', 'spread': '13.09', 'groupId': 'OG002', 'lowerLimit': '77.4', 'upperLimit': '84.3'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.7', 'ciLowerLimit': '-20.2', 'ciUpperLimit': '-11.1', 'pValueComment': 'p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.', 'groupDescription': 'LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence. Planned power of at least 89% assumed a mean difference of 15 to 30 points and a standard deviation of paired differences of 15 to 20 points, with conservative multiple comparison adjustment for alpha of 0.025.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.4', 'ciLowerLimit': '8.9', 'ciUpperLimit': '18.0', 'pValueComment': 'p-value adjusted for multiple comparisons with Hochberg adjustment.', 'groupDescription': 'LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.1', 'ciLowerLimit': '24.6', 'ciUpperLimit': '33.7', 'pValueComment': 'p-value adjusted for multiple comparisons with Hochberg adjustment.', 'groupDescription': 'LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). Emax = Maximum observed score.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'PRIMARY', 'title': 'High: Area Under Effect Curve (AUE) From 0-2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '7.34', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '11.5'}, {'value': '26.9', 'spread': '27.72', 'groupId': 'OG001', 'lowerLimit': '18.3', 'upperLimit': '36.0'}, {'value': '77.5', 'spread': '34.40', 'groupId': 'OG002', 'lowerLimit': '69.4', 'upperLimit': '87.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-51.1', 'ciLowerLimit': '-61.2', 'ciUpperLimit': '-41.0', 'pValueComment': 'p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.', 'groupDescription': 'LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.6', 'ciLowerLimit': '14.5', 'ciUpperLimit': '34.6', 'pValueComment': 'p-value adjusted for multiple comparisons with Hochberg adjustment.', 'groupDescription': 'LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '75.7', 'ciLowerLimit': '65.6', 'ciUpperLimit': '85.8', 'pValueComment': 'p-value adjusted for multiple comparisons with Hochberg adjustment.', 'groupDescription': 'LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '1.82', 'groupId': 'OG000', 'lowerLimit': '35.7', 'upperLimit': '40.2'}, {'value': '43.1', 'spread': '6.11', 'groupId': 'OG001', 'lowerLimit': '40.9', 'upperLimit': '45.4'}, {'value': '51.8', 'spread': '10.12', 'groupId': 'OG002', 'lowerLimit': '49.8', 'upperLimit': '54.3'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.9', 'ciLowerLimit': '-11.8', 'ciUpperLimit': '-6.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '2.3', 'ciUpperLimit': '8.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.1', 'ciLowerLimit': '11.2', 'ciUpperLimit': '17.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).', 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Drug Liking: Area Under Effect Curve (AUE) From 0-4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '188.6', 'spread': '7.56', 'groupId': 'OG000', 'lowerLimit': '179.1', 'upperLimit': '199.1'}, {'value': '217.9', 'spread': '24.72', 'groupId': 'OG001', 'lowerLimit': '208.1', 'upperLimit': '228.2'}, {'value': '265.6', 'spread': '44.44', 'groupId': 'OG002', 'lowerLimit': '256.9', 'upperLimit': '276.9'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-48.8', 'ciLowerLimit': '-62.0', 'ciUpperLimit': '-35.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.0', 'ciLowerLimit': '15.8', 'ciUpperLimit': '42.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '77.8', 'ciLowerLimit': '64.5', 'ciUpperLimit': '91.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).', 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '390.3', 'spread': '15.19', 'groupId': 'OG000', 'lowerLimit': '368.4', 'upperLimit': '411.1'}, {'value': '447.3', 'spread': '60.82', 'groupId': 'OG001', 'lowerLimit': '424.9', 'upperLimit': '467.6'}, {'value': '514.4', 'spread': '87.10', 'groupId': 'OG002', 'lowerLimit': '493.4', 'upperLimit': '536.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-68.6', 'ciLowerLimit': '-95.0', 'ciUpperLimit': '-42.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '56.5', 'ciLowerLimit': '30.1', 'ciUpperLimit': '82.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '125.1', 'ciLowerLimit': '98.7', 'ciUpperLimit': '151.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).', 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '591.0', 'spread': '20.36', 'groupId': 'OG000', 'lowerLimit': '560.2', 'upperLimit': '619.4'}, {'value': '658.2', 'spread': '81.77', 'groupId': 'OG001', 'lowerLimit': '626.7', 'upperLimit': '685.9'}, {'value': '732.9', 'spread': '122.81', 'groupId': 'OG002', 'lowerLimit': '702.7', 'upperLimit': '761.9'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-76.0', 'ciLowerLimit': '-112.8', 'ciUpperLimit': '-39.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '66.5', 'ciLowerLimit': '29.8', 'ciUpperLimit': '103.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '142.5', 'ciLowerLimit': '105.7', 'ciUpperLimit': '179.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).', 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1192.1', 'spread': '29.73', 'groupId': 'OG000', 'lowerLimit': '1150.1', 'upperLimit': '1230.7'}, {'value': '1263.0', 'spread': '101.88', 'groupId': 'OG001', 'lowerLimit': '1220.0', 'upperLimit': '1300.5'}, {'value': '1348.2', 'spread': '174.53', 'groupId': 'OG002', 'lowerLimit': '1306.1', 'upperLimit': '1386.8'}]}]}], 'analyses': [{'pValue': '0.0011', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-86.2', 'ciLowerLimit': '-136.5', 'ciUpperLimit': '-35.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0071', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.8', 'ciLowerLimit': '19.7', 'ciUpperLimit': '120.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '156.0', 'ciLowerLimit': '105.7', 'ciUpperLimit': '206.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).', 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Drug Liking: Time to Maximum (Peak) Effect (TEmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '6.83', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '7.5'}, {'value': '4.8', 'spread': '5.74', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '6.5'}, {'value': '2.7', 'spread': '2.63', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '4.5'}]}]}], 'analyses': [{'pValue': '0.1254', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '4.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4592', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '1.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0251', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '-0.4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). TEmax = Time to maximum observed score.', 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'High: Area Under Effect Curve (AUE) From 0-1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '2.87', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '5.2'}, {'value': '10.3', 'spread': '12.26', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '14.5'}, {'value': '25.5', 'spread': '16.26', 'groupId': 'OG002', 'lowerLimit': '21.7', 'upperLimit': '29.9'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.4', 'ciLowerLimit': '-19.9', 'ciUpperLimit': '-11.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.3', 'ciLowerLimit': '4.8', 'ciUpperLimit': '13.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.7', 'ciLowerLimit': '20.3', 'ciUpperLimit': '29.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'High: Area Under Effect Curve (AUE) From 0-4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '13.28', 'groupId': 'OG000', 'lowerLimit': '-12.5', 'upperLimit': '21.9'}, {'value': '63.6', 'spread': '53.04', 'groupId': 'OG001', 'lowerLimit': '47.2', 'upperLimit': '81.7'}, {'value': '178.9', 'spread': '64.56', 'groupId': 'OG002', 'lowerLimit': '163.2', 'upperLimit': '197.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-116.1', 'ciLowerLimit': '-136.5', 'ciUpperLimit': '-95.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.7', 'ciLowerLimit': '39.3', 'ciUpperLimit': '80.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '175.8', 'ciLowerLimit': '155.4', 'ciUpperLimit': '196.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'High: Area Under Effect Curve (AUE) From 0-8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '23.15', 'groupId': 'OG000', 'lowerLimit': '-23.1', 'upperLimit': '39.2'}, {'value': '129.5', 'spread': '101.43', 'groupId': 'OG001', 'lowerLimit': '99.4', 'upperLimit': '161.6'}, {'value': '330.5', 'spread': '109.02', 'groupId': 'OG002', 'lowerLimit': '301.5', 'upperLimit': '363.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-202.2', 'ciLowerLimit': '-239.0', 'ciUpperLimit': '-165.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '122.5', 'ciLowerLimit': '85.7', 'ciUpperLimit': '159.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '324.6', 'ciLowerLimit': '287.7', 'ciUpperLimit': '361.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'High: Area Under Effect Curve (AUE) From 0-12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '28.80', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '49.8'}, {'value': '160.7', 'spread': '129.72', 'groupId': 'OG001', 'lowerLimit': '121.5', 'upperLimit': '201.7'}, {'value': '412.3', 'spread': '142.08', 'groupId': 'OG002', 'lowerLimit': '374.4', 'upperLimit': '454.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-253.0', 'ciLowerLimit': '-301.5', 'ciUpperLimit': '-204.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '151.9', 'ciLowerLimit': '103.5', 'ciUpperLimit': '200.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '404.9', 'ciLowerLimit': '356.4', 'ciUpperLimit': '453.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'High: Area Under Effect Curve (AUE) From 0-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '35.41', 'groupId': 'OG000', 'lowerLimit': '-39.6', 'upperLimit': '65.1'}, {'value': '180.3', 'spread': '149.07', 'groupId': 'OG001', 'lowerLimit': '129.0', 'upperLimit': '233.8'}, {'value': '485.4', 'spread': '204.51', 'groupId': 'OG002', 'lowerLimit': '435.7', 'upperLimit': '540.6'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-306.8', 'ciLowerLimit': '-370.9', 'ciUpperLimit': '-242.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '168.6', 'ciLowerLimit': '104.7', 'ciUpperLimit': '232.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '475.4', 'ciLowerLimit': '411.3', 'ciUpperLimit': '539.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'High: Time to Maximum (Peak) Effect (TEmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.3'}, {'value': '2.7', 'spread': '1.94', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.3'}, {'value': '2.5', 'spread': '1.94', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '3.1'}]}]}], 'analyses': [{'pValue': '0.5607', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '1.2', 'ciUpperLimit': '2.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '1.0', 'ciUpperLimit': '2.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.", 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Good Effects: Area Under Effect Curve (AUE) From 0-1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '2.47', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '5.5'}, {'value': '12.2', 'spread': '13.74', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '16.7'}, {'value': '27.2', 'spread': '17.64', 'groupId': 'OG002', 'lowerLimit': '23.0', 'upperLimit': '32.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-20.3', 'ciUpperLimit': '-10.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.2', 'ciLowerLimit': '6.3', 'ciUpperLimit': '16.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.5', 'ciLowerLimit': '21.5', 'ciUpperLimit': '31.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '6.69', 'groupId': 'OG000', 'lowerLimit': '-7.4', 'upperLimit': '12.2'}, {'value': '30.4', 'spread': '29.84', 'groupId': 'OG001', 'lowerLimit': '20.9', 'upperLimit': '40.5'}, {'value': '77.4', 'spread': '38.39', 'groupId': 'OG002', 'lowerLimit': '68.6', 'upperLimit': '88.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-47.7', 'ciLowerLimit': '-59.5', 'ciUpperLimit': '-35.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.3', 'ciLowerLimit': '16.5', 'ciUpperLimit': '40.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '76.0', 'ciLowerLimit': '64.2', 'ciUpperLimit': '87.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Good Effects: Area Under Effect Curve (AUE) From 0-4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '12.35', 'groupId': 'OG000', 'lowerLimit': '-14.8', 'upperLimit': '23.5'}, {'value': '70.5', 'spread': '58.34', 'groupId': 'OG001', 'lowerLimit': '52.2', 'upperLimit': '90.5'}, {'value': '178.5', 'spread': '73.28', 'groupId': 'OG002', 'lowerLimit': '161.4', 'upperLimit': '199.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-109.3', 'ciLowerLimit': '-132.9', 'ciUpperLimit': '-85.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '67.0', 'ciLowerLimit': '43.5', 'ciUpperLimit': '90.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '176.3', 'ciLowerLimit': '152.6', 'ciUpperLimit': '199.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '22.44', 'groupId': 'OG000', 'lowerLimit': '-28.8', 'upperLimit': '42.5'}, {'value': '141.2', 'spread': '120.31', 'groupId': 'OG001', 'lowerLimit': '105.9', 'upperLimit': '177.2'}, {'value': '330.0', 'spread': '122.85', 'groupId': 'OG002', 'lowerLimit': '296.6', 'upperLimit': '368.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-190.8', 'ciLowerLimit': '-234.2', 'ciUpperLimit': '-147.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '134.7', 'ciLowerLimit': '91.5', 'ciUpperLimit': '178.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '325.5', 'ciLowerLimit': '282.1', 'ciUpperLimit': '368.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '28.24', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '53.9'}, {'value': '174.6', 'spread': '153.23', 'groupId': 'OG001', 'lowerLimit': '129.0', 'upperLimit': '220.4'}, {'value': '417.4', 'spread': '158.39', 'groupId': 'OG002', 'lowerLimit': '373.8', 'upperLimit': '465.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-244.9', 'ciLowerLimit': '-302.0', 'ciUpperLimit': '-187.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '166.5', 'ciLowerLimit': '109.5', 'ciUpperLimit': '223.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '411.4', 'ciLowerLimit': '354.3', 'ciUpperLimit': '468.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '34.73', 'groupId': 'OG000', 'lowerLimit': '-47.8', 'upperLimit': '70.1'}, {'value': '196.0', 'spread': '176.48', 'groupId': 'OG001', 'lowerLimit': '137.4', 'upperLimit': '255.3'}, {'value': '503.8', 'spread': '223.88', 'groupId': 'OG002', 'lowerLimit': '447.3', 'upperLimit': '565.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-310.0', 'ciLowerLimit': '-384.5', 'ciUpperLimit': '-235.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '185.2', 'ciLowerLimit': '110.8', 'ciUpperLimit': '259.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '495.1', 'ciLowerLimit': '420.6', 'ciUpperLimit': '569.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Good Effects: Peak Effect (Emax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '5.38', 'groupId': 'OG000', 'lowerLimit': '-4.6', 'upperLimit': '8.6'}, {'value': '32.6', 'spread': '23.74', 'groupId': 'OG001', 'lowerLimit': '26.2', 'upperLimit': '39.4'}, {'value': '63.0', 'spread': '20.71', 'groupId': 'OG002', 'lowerLimit': '56.7', 'upperLimit': '69.9'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.5', 'ciLowerLimit': '-38.7', 'ciUpperLimit': '-22.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.8', 'ciLowerLimit': '22.6', 'ciUpperLimit': '39.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '61.3', 'ciLowerLimit': '53.1', 'ciUpperLimit': '69.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Good Effects: Time to Maximum (Peak) Effect (TEmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.4'}, {'value': '2.5', 'spread': '2.13', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '3.3'}, {'value': '2.6', 'spread': '2.47', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '3.3'}]}]}], 'analyses': [{'pValue': '0.8671', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '0.9', 'ciUpperLimit': '2.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.0', 'ciUpperLimit': '2.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.", 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Any Effects: Area Under Effect Curve (AUE) From 0-1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '2.23', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '4.9'}, {'value': '9.8', 'spread': '12.17', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '13.7'}, {'value': '22.6', 'spread': '14.89', 'groupId': 'OG002', 'lowerLimit': '19.0', 'upperLimit': '26.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.0', 'ciLowerLimit': '-17.0', 'ciUpperLimit': '-9.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.8', 'ciLowerLimit': '4.8', 'ciUpperLimit': '12.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.8', 'ciLowerLimit': '17.8', 'ciUpperLimit': '25.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '6.41', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '11.3'}, {'value': '26.7', 'spread': '28.59', 'groupId': 'OG001', 'lowerLimit': '18.4', 'upperLimit': '35.9'}, {'value': '71.5', 'spread': '33.15', 'groupId': 'OG002', 'lowerLimit': '63.7', 'upperLimit': '81.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.3', 'ciLowerLimit': '-55.3', 'ciUpperLimit': '-35.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.5', 'ciLowerLimit': '14.6', 'ciUpperLimit': '34.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '69.8', 'ciLowerLimit': '59.9', 'ciUpperLimit': '79.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Any Effects: Area Under Effect Curve (AUE) From 0-4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '11.95', 'groupId': 'OG000', 'lowerLimit': '-12.2', 'upperLimit': '21.8'}, {'value': '63.8', 'spread': '54.35', 'groupId': 'OG001', 'lowerLimit': '47.9', 'upperLimit': '81.9'}, {'value': '172.2', 'spread': '62.60', 'groupId': 'OG002', 'lowerLimit': '156.9', 'upperLimit': '191.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-109.1', 'ciLowerLimit': '-129.3', 'ciUpperLimit': '-88.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '60.1', 'ciLowerLimit': '39.9', 'ciUpperLimit': '80.4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '169.2', 'ciLowerLimit': '148.9', 'ciUpperLimit': '189.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '22.45', 'groupId': 'OG000', 'lowerLimit': '-21.4', 'upperLimit': '38.4'}, {'value': '125.6', 'spread': '94.76', 'groupId': 'OG001', 'lowerLimit': '97.3', 'upperLimit': '157.1'}, {'value': '331.8', 'spread': '105.57', 'groupId': 'OG002', 'lowerLimit': '304.3', 'upperLimit': '364.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-207.0', 'ciLowerLimit': '-242.0', 'ciUpperLimit': '-172.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '118.7', 'ciLowerLimit': '83.9', 'ciUpperLimit': '153.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '325.8', 'ciLowerLimit': '290.8', 'ciUpperLimit': '360.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '27.85', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '48.2'}, {'value': '155.4', 'spread': '117.10', 'groupId': 'OG001', 'lowerLimit': '119.3', 'upperLimit': '195.2'}, {'value': '422.5', 'spread': '136.00', 'groupId': 'OG002', 'lowerLimit': '387.5', 'upperLimit': '463.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-268.2', 'ciLowerLimit': '-313.2', 'ciUpperLimit': '-223.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '147.0', 'ciLowerLimit': '102.1', 'ciUpperLimit': '191.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '415.2', 'ciLowerLimit': '370.2', 'ciUpperLimit': '460.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '33.80', 'groupId': 'OG000', 'lowerLimit': '-36.0', 'upperLimit': '62.7'}, {'value': '176.4', 'spread': '130.79', 'groupId': 'OG001', 'lowerLimit': '129.6', 'upperLimit': '228.3'}, {'value': '510.8', 'spread': '194.67', 'groupId': 'OG002', 'lowerLimit': '465.6', 'upperLimit': '564.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-336.0', 'ciLowerLimit': '-395.4', 'ciUpperLimit': '-276.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '165.6', 'ciLowerLimit': '106.4', 'ciUpperLimit': '224.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '501.6', 'ciLowerLimit': '442.2', 'ciUpperLimit': '561.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Any Effects: Peak Effect (Emax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '5.35', 'groupId': 'OG000', 'lowerLimit': '-3.3', 'upperLimit': '8.1'}, {'value': '28.7', 'spread': '20.03', 'groupId': 'OG001', 'lowerLimit': '23.3', 'upperLimit': '34.8'}, {'value': '62.4', 'spread': '18.59', 'groupId': 'OG002', 'lowerLimit': '57.1', 'upperLimit': '68.5'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.8', 'ciLowerLimit': '-40.7', 'ciUpperLimit': '-26.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.7', 'ciLowerLimit': '19.7', 'ciUpperLimit': '33.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '60.4', 'ciLowerLimit': '53.4', 'ciUpperLimit': '67.4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Any Effects: Time to Maximum (Peak) Effect (TEmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.4'}, {'value': '3.1', 'spread': '2.34', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '3.8'}, {'value': '2.8', 'spread': '2.03', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '3.4'}]}]}], 'analyses': [{'pValue': '0.3345', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '1.5', 'ciUpperLimit': '3.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '1.1', 'ciUpperLimit': '2.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.", 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.92', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '1.1'}, {'value': '0.6', 'spread': '1.24', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '1.4'}, {'value': '1.5', 'spread': '3.70', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '2.4'}]}]}], 'analyses': [{'pValue': '0.0453', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '-0.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5637', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0110', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.3', 'ciUpperLimit': '2.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '1.65', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '3.5'}, {'value': '2.6', 'spread': '4.40', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '5.5'}, {'value': '7.4', 'spread': '12.50', 'groupId': 'OG002', 'lowerLimit': '5.1', 'upperLimit': '10.4'}]}]}], 'analyses': [{'pValue': '0.0041', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '-1.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2178', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '5.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.0', 'ciLowerLimit': '3.7', 'ciUpperLimit': '10.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Bad Effects: Area Under Effect Curve (AUE) From 0-4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '3.20', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '9.3'}, {'value': '7.7', 'spread': '13.27', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '16.2'}, {'value': '27.1', 'spread': '36.06', 'groupId': 'OG002', 'lowerLimit': '20.3', 'upperLimit': '35.6'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.4', 'ciLowerLimit': '-28.8', 'ciUpperLimit': '-9.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1510', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.9', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '16.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.2', 'ciLowerLimit': '16.8', 'ciUpperLimit': '35.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '5.84', 'groupId': 'OG000', 'lowerLimit': '-14.0', 'upperLimit': '20.9'}, {'value': '19.7', 'spread': '37.56', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '39.4'}, {'value': '74.6', 'spread': '80.92', 'groupId': 'OG002', 'lowerLimit': '59.7', 'upperLimit': '94.6'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-55.2', 'ciLowerLimit': '-75.9', 'ciUpperLimit': '-34.4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0796', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.5', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '39.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '73.6', 'ciLowerLimit': '52.9', 'ciUpperLimit': '94.4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '7.82', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30.2'}, {'value': '28.4', 'spread': '56.67', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '57.1'}, {'value': '110.3', 'spread': '116.60', 'groupId': 'OG002', 'lowerLimit': '89.2', 'upperLimit': '140.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-82.8', 'ciLowerLimit': '-112.9', 'ciUpperLimit': '-52.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0780', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.9', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '56.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '109.7', 'ciLowerLimit': '79.6', 'ciUpperLimit': '139.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '13.62', 'groupId': 'OG000', 'lowerLimit': '-27.7', 'upperLimit': '41.7'}, {'value': '36.8', 'spread': '76.50', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '75.6'}, {'value': '147.2', 'spread': '157.74', 'groupId': 'OG002', 'lowerLimit': '118.1', 'upperLimit': '187.6'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-111.9', 'ciLowerLimit': '-153.7', 'ciUpperLimit': '-70.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1089', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.9', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '75.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '145.8', 'ciLowerLimit': '104.1', 'ciUpperLimit': '187.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Bad Effects: Peak Effect (Emax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '1.60', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '5.4'}, {'value': '6.6', 'spread': '10.30', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '11.4'}, {'value': '20.1', 'spread': '18.98', 'groupId': 'OG002', 'lowerLimit': '16.3', 'upperLimit': '25.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.7', 'ciLowerLimit': '-18.8', 'ciUpperLimit': '-8.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0215', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '0.9', 'ciUpperLimit': '11.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.7', 'ciLowerLimit': '14.6', 'ciUpperLimit': '24.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Bad Effects: Time to Maximum (Peak) Effect (TEmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '1.60', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.9'}, {'value': '2.2', 'spread': '2.38', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '3.2'}, {'value': '4.5', 'spread': '3.56', 'groupId': 'OG002', 'lowerLimit': '3.7', 'upperLimit': '5.5'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '-1.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0455', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.0', 'ciUpperLimit': '2.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '2.3', 'ciUpperLimit': '4.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.", 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Nausea: Area Under Effect Curve (AUE) From 0-1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '1.28', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.5', 'spread': '1.16', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.1'}, {'value': '0.8', 'spread': '2.25', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '1.4'}]}]}], 'analyses': [{'pValue': '0.3749', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7939', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2524', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '1.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5 and 1 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Nausea: Area Under Effect Curve (AUE) From 0-2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.73', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '2.7'}, {'value': '2.1', 'spread': '4.12', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '4.1'}, {'value': '3.7', 'spread': '8.14', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '5.8'}]}]}], 'analyses': [{'pValue': '0.1211', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '0.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1997', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '3.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0057', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '5.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). 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AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Nausea: Area Under Effect Curve (AUE) From 0-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '13.69', 'groupId': 'OG000', 'lowerLimit': '-26.9', 'upperLimit': '44.4'}, {'value': '35.3', 'spread': '76.53', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '76.3'}, {'value': '108.3', 'spread': '171.22', 'groupId': 'OG002', 'lowerLimit': '80.7', 'upperLimit': '152.1'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-75.8', 'ciLowerLimit': '-118.6', 'ciUpperLimit': '-33.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1410', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.8', 'ciLowerLimit': '-10.8', 'ciUpperLimit': '74.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '107.7', 'ciLowerLimit': '64.9', 'ciUpperLimit': '150.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Nausea: Peak Effect (Emax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '2.41', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '5.3'}, {'value': '5.2', 'spread': '10.41', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '9.6'}, {'value': '14.9', 'spread': '17.14', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '19.6'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.0', 'ciLowerLimit': '-14.4', 'ciUpperLimit': '-5.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0529', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '8.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.3', 'ciLowerLimit': '9.9', 'ciUpperLimit': '18.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Nausea: Time to Maximum (Peak) Effect (TEmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '4.17', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.9'}, {'value': '2.5', 'spread': '4.69', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '4.0'}, {'value': '4.3', 'spread': '3.52', 'groupId': 'OG002', 'lowerLimit': '2.9', 'upperLimit': '5.8'}]}]}], 'analyses': [{'pValue': '0.0806', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '0.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2769', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '3.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0056', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '0.9', 'ciUpperLimit': '5.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.", 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '1.09', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '1.2'}, {'value': '0.3', 'spread': '0.86', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '1.1'}, {'value': '1.0', 'spread': '3.50', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '1.9'}]}]}], 'analyses': [{'pValue': '0.1100', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9421', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1266', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '1.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '1.75', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '3.1'}, {'value': '1.7', 'spread': '4.25', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '4.1'}, {'value': '4.2', 'spread': '10.19', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '6.7'}]}]}], 'analyses': [{'pValue': '0.0723', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '0.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4515', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '3.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0121', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '0.8', 'ciUpperLimit': '6.4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Feel Sick: Area Under Effect Curve (AUE) From 0-4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '3.22', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '8.0'}, {'value': '5.2', 'spread': '12.28', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '12.2'}, {'value': '16.1', 'spread': '28.88', 'groupId': 'OG002', 'lowerLimit': '10.6', 'upperLimit': '23.2'}]}]}], 'analyses': [{'pValue': '0.0059', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.0', 'ciLowerLimit': '-18.7', 'ciUpperLimit': '-3.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2800', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '11.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.1', 'ciLowerLimit': '7.5', 'ciUpperLimit': '22.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '6.27', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '35.83', 'groupId': 'OG001'}, {'value': '50.7', 'spread': '72.35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.7', 'ciLowerLimit': '-54.8', 'ciUpperLimit': '-18.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1488', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.2', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '31.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.9', 'ciLowerLimit': '31.8', 'ciUpperLimit': '67.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '8.53', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '54.79', 'groupId': 'OG001'}, {'value': '80.9', 'spread': '113.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-60.1', 'ciLowerLimit': '-88.5', 'ciUpperLimit': '-31.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1556', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.4', 'ciLowerLimit': '-8.0', 'ciUpperLimit': '48.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '80.4', 'ciLowerLimit': '52.0', 'ciUpperLimit': '108.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '14.72', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '73.35', 'groupId': 'OG001'}, {'value': '112.8', 'spread': '160.44', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-84.0', 'ciLowerLimit': '-124.8', 'ciUpperLimit': '-43.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1826', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.4', 'ciLowerLimit': '-13.3', 'ciUpperLimit': '68.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '111.4', 'ciLowerLimit': '70.6', 'ciUpperLimit': '152.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Feel Sick: Peak Effect (Emax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '11.06', 'groupId': 'OG001'}, {'value': '16.4', 'spread': '17.38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.7', 'ciLowerLimit': '-16.4', 'ciUpperLimit': '-7.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0811', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '8.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.9', 'ciLowerLimit': '11.1', 'ciUpperLimit': '20.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Feel Sick: Time to Maximum (Peak) Effect (TEmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '3.45', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '-1.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1631', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '2.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '2.1', 'ciUpperLimit': '4.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.", 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '6.57', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '5.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2117', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '0.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0345', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '0.2', 'ciUpperLimit': '4.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '1.4', 'ciUpperLimit': '5.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr(0-1).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '12.63', 'groupId': 'OG001'}, {'value': '21.3', 'spread': '21.28', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.2', 'ciLowerLimit': '-18.4', 'ciUpperLimit': '-6.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.4', 'ciLowerLimit': '2.3', 'ciUpperLimit': '14.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.6', 'ciLowerLimit': '14.4', 'ciUpperLimit': '26.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Sleepy: Area Under Effect Curve (AUE) From 0-4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '35.9', 'spread': '38.78', 'groupId': 'OG001'}, {'value': '74.2', 'spread': '61.41', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.2', 'ciLowerLimit': '-55.6', 'ciUpperLimit': '-20.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.4', 'ciLowerLimit': '17.0', 'ciUpperLimit': '51.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '72.6', 'ciLowerLimit': '55.2', 'ciUpperLimit': '90.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of EMBEDA solution containing 120 mg morphine sulfate / 4.8 mg naltrexone hydrochloride administered orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '10.15', 'groupId': 'OG000'}, {'value': '97.6', 'spread': '103.13', 'groupId': 'OG001'}, {'value': '199.2', 'spread': '141.96', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-100.3', 'ciLowerLimit': '-142.2', 'ciUpperLimit': '-58.4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '93.9', 'ciLowerLimit': '52.1', 'ciUpperLimit': '135.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '194.2', 'ciLowerLimit': '152.3', 'ciUpperLimit': '236.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'spread': '13.05', 'groupId': 'OG000'}, {'value': '138.5', 'spread': '140.93', 'groupId': 'OG001'}, {'value': '287.5', 'spread': '196.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-147.4', 'ciLowerLimit': '-205.1', 'ciUpperLimit': '-89.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '134.1', 'ciLowerLimit': '76.5', 'ciUpperLimit': '191.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '281.5', 'ciLowerLimit': '223.7', 'ciUpperLimit': '339.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '21.06', 'groupId': 'OG000'}, {'value': '175.5', 'spread': '175.65', 'groupId': 'OG001'}, {'value': '378.7', 'spread': '267.76', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-201.4', 'ciLowerLimit': '-279.3', 'ciUpperLimit': '-123.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '169.1', 'ciLowerLimit': '91.5', 'ciUpperLimit': '246.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '370.5', 'ciLowerLimit': '292.7', 'ciUpperLimit': '448.4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Sleepy: Peak Effect (Emax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '22.75', 'groupId': 'OG001'}, {'value': '43.9', 'spread': '21.93', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.4', 'ciLowerLimit': '-23.8', 'ciUpperLimit': '-9.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.7', 'ciLowerLimit': '18.3', 'ciUpperLimit': '33.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.1', 'ciLowerLimit': '34.7', 'ciUpperLimit': '49.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Sleepy: Time to Maximum (Peak) Effect (TEmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.94', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '2.81', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0253', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '-0.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '1.6', 'ciUpperLimit': '4.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '3.0', 'ciUpperLimit': '5.4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.", 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.41', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '5.73', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0062', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '-0.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4998', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '2.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '1.1', 'ciUpperLimit': '4.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '6.26', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '15.14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.0', 'ciLowerLimit': '-11.1', 'ciUpperLimit': '-3.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2693', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '6.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.3', 'ciLowerLimit': '5.3', 'ciUpperLimit': '13.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Dizzy: Area Under Effect Curve (AUE) From 0-4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '2.93', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '21.81', 'groupId': 'OG001'}, {'value': '26.1', 'spread': '41.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0042', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.2', 'ciLowerLimit': '-27.2', 'ciUpperLimit': '-5.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1139', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.7', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '19.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.0', 'ciLowerLimit': '14.1', 'ciUpperLimit': '35.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'PRIMARY', 'title': 'High: Peak Effect (Emax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '5.73', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '8.1'}, {'value': '29.2', 'spread': '20.72', 'groupId': 'OG001', 'lowerLimit': '23.6', 'upperLimit': '35.3'}, {'value': '64.1', 'spread': '18.85', 'groupId': 'OG002', 'lowerLimit': '58.5', 'upperLimit': '70.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.9', 'ciLowerLimit': '-42.1', 'ciUpperLimit': '-27.7', 'pValueComment': 'p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.', 'groupDescription': 'LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.2', 'ciLowerLimit': '20.1', 'ciUpperLimit': '34.4', 'pValueComment': 'p-value adjusted for multiple comparisons with Hochberg adjustment.', 'groupDescription': 'LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '62.1', 'ciLowerLimit': '54.9', 'ciUpperLimit': '69.4', 'pValueComment': 'p-value adjusted for multiple comparisons with Hochberg adjustment.', 'groupDescription': 'LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '5.93', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '51.17', 'groupId': 'OG001'}, {'value': '56.7', 'spread': '87.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.1', 'ciLowerLimit': '-58.5', 'ciUpperLimit': '-11.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.3', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '42.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54.4', 'ciLowerLimit': '31.0', 'ciUpperLimit': '77.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '8.68', 'groupId': 'OG000'}, {'value': '27.4', 'spread': '66.65', 'groupId': 'OG001'}, {'value': '71.4', 'spread': '111.82', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0051', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-43.3', 'ciLowerLimit': '-73.1', 'ciUpperLimit': '-13.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0941', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.3', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '55.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.6', 'ciLowerLimit': '38.8', 'ciUpperLimit': '98.4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '14.73', 'groupId': 'OG000'}, {'value': '36.0', 'spread': '82.99', 'groupId': 'OG001'}, {'value': '85.5', 'spread': '135.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0083', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.0', 'ciLowerLimit': '-85.0', 'ciUpperLimit': '-13.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0766', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.3', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '68.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '81.3', 'ciLowerLimit': '45.4', 'ciUpperLimit': '117.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).", 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Dizzy: Peak Effect (Emax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '11.18', 'groupId': 'OG001'}, {'value': '13.7', 'spread': '17.66', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0018', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.0', 'ciLowerLimit': '-12.9', 'ciUpperLimit': '-3.1', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0527', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.8', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '9.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.8', 'ciLowerLimit': '7.9', 'ciUpperLimit': '17.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Dizzy: Time to Maximum (Peak) Effect (TEmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.57', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '2.60', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3986', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '0.6', 'ciUpperLimit': '2.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.0', 'ciUpperLimit': '2.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.", 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Overall Drug Liking Effect at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.6', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '58.8', 'spread': '17.68', 'groupId': 'OG001'}, {'value': '69.8', 'spread': '20.23', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0029', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.2', 'ciLowerLimit': '-18', 'ciUpperLimit': '-4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0286', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.1', 'ciLowerLimit': '1', 'ciUpperLimit': '15', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.3', 'ciLowerLimit': '12', 'ciUpperLimit': '27', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24 hrs post dose', 'description': 'Overall drug liking VAS assesses the participant\'s global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm= "neither like nor dislike", and 100 mm= "strong liking").', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Take Drug Again Effect at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '4.41', 'groupId': 'OG000'}, {'value': '58.0', 'spread': '21.90', 'groupId': 'OG001'}, {'value': '70.6', 'spread': '24.53', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0050', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.0', 'ciLowerLimit': '-22', 'ciUpperLimit': '-4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0700', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.2', 'ciLowerLimit': '-1', 'ciUpperLimit': '17', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.2', 'ciLowerLimit': '12', 'ciUpperLimit': '30', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24 hrs post dose', 'description': 'Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would").', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '0.60', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.5', 'ciUpperLimit': '0.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '-1.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5 and 1 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).', 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '-4.1', 'spread': '1.31', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '1.9', 'ciUpperLimit': '2.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '-1.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '-3.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).', 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Pupillometry: Area Under Effect Curve (AUE) From 0-4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '2.29', 'groupId': 'OG001'}, {'value': '-10.3', 'spread': '2.58', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.9', 'ciLowerLimit': '3.9', 'ciUpperLimit': '5.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '-4.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.1', 'ciLowerLimit': '-11.1', 'ciUpperLimit': '-9.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).', 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '3.25', 'groupId': 'OG000'}, {'value': '-13.8', 'spread': '4.36', 'groupId': 'OG001'}, {'value': '-22.5', 'spread': '5.35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.6', 'ciLowerLimit': '6.6', 'ciUpperLimit': '10.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.8', 'ciLowerLimit': '-15.9', 'ciUpperLimit': '-11.8', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.4', 'ciLowerLimit': '-24.5', 'ciUpperLimit': '-20.4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).', 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '-20.8', 'spread': '6.80', 'groupId': 'OG001'}, {'value': '-32.6', 'spread': '7.95', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.7', 'ciLowerLimit': '8.7', 'ciUpperLimit': '14.7', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.5', 'ciLowerLimit': '-24.5', 'ciUpperLimit': '-18.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.2', 'ciLowerLimit': '-36.2', 'ciUpperLimit': '-30.2', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).', 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '9.19', 'groupId': 'OG000'}, {'value': '-34.2', 'spread': '13.96', 'groupId': 'OG001'}, {'value': '-51.8', 'spread': '15.26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.5', 'ciLowerLimit': '11.6', 'ciUpperLimit': '23.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.7', 'ciLowerLimit': '-43.6', 'ciUpperLimit': '-31.9', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-55.2', 'ciLowerLimit': '-61.1', 'ciUpperLimit': '-49.3', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).', 'unitOfMeasure': 'hrs*mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Pupillometry: Peak Effect (Emax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '0.74', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.4', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-1.5', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '-2.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. Emax = Smallest post-dose pupil size.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Pupillometry: Time to Maximum (Peak) Effect (TEmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Single dose of matching placebo solution orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG002', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '6.83', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '1.64', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0262', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '0.3', 'ciUpperLimit': '4.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4180', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '3.0', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1479', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '0.6', 'groupDescription': 'LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to smallest post-dose pupil size.', 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0181', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.21', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.35', 'groupDescription': 'Tmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug in the Treatment Phase.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '79308.6', 'spread': '31555.86', 'groupId': 'OG000'}, {'value': '103621', 'spread': '34005.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.75', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.83', 'groupDescription': 'Natural log transformed Cmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'unitOfMeasure': 'picogram/milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug in the Treatment Phase.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '52644.9', 'spread': '19951.60', 'groupId': 'OG000'}, {'value': '67920.1', 'spread': '24702.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.77', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.86', 'groupDescription': 'Natural log transformed AUC (0-1) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5 and 1 hrs post-dose', 'description': 'AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).', 'unitOfMeasure': 'hrs*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug in the Treatment Phase.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '112989', 'spread': '33784.6', 'groupId': 'OG000'}, {'value': '129721', 'spread': '39670.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0065', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.86', 'ciLowerLimit': '0.79', 'ciUpperLimit': '0.94', 'groupDescription': 'Natural log transformed AUC (0-2) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose', 'description': 'AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).', 'unitOfMeasure': 'hrs*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug in the Treatment Phase.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '197745', 'spread': '54807.4', 'groupId': 'OG000'}, {'value': '199442', 'spread': '60559.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6399', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.98', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.06', 'groupDescription': 'Natural log transformed AUC (0-4) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': 'AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).', 'unitOfMeasure': 'hrs*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug in the Treatment Phase.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '269743', 'spread': '77664.5', 'groupId': 'OG000'}, {'value': '263270', 'spread': '76706.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9057', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.00', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.08', 'groupDescription': 'Natural log transformed AUC (0-8) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': 'AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).', 'unitOfMeasure': 'hrs*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug in the Treatment Phase.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '303428', 'spread': '86669.9', 'groupId': 'OG000'}, {'value': '288324', 'spread': '81697.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4250', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.03', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.10', 'groupDescription': 'Natural log transformed AUC (0-12) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': 'AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).', 'unitOfMeasure': 'hrs*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug in the Treatment Phase.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '376260', 'spread': '104635.5', 'groupId': 'OG000'}, {'value': '335357', 'spread': '91242.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0204', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.10', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.18', 'groupDescription': 'Natural log transformed AUC (0-24) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).', 'unitOfMeasure': 'hrs*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug in the Treatment Phase.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Morphine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}, {'id': 'OG001', 'title': 'Morphine', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '551755', 'spread': '476987.0', 'groupId': 'OG000'}, {'value': '369270', 'spread': '98821.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.32', 'ciLowerLimit': '1.17', 'ciUpperLimit': '1.49', 'groupDescription': 'Natural log transformed AUC (0-∞) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).', 'unitOfMeasure': 'hrs*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug in the Treatment Phase.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug in the Treatment Phase.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Naltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '978.83', 'spread': '713.748', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug in the Treatment Phase.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EMBEDA', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '619.24', 'spread': '441.602', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.5 and 1 hrs post-dose', 'description': 'AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).', 'unitOfMeasure': 'hrs*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all 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Participants in this group were assigned to morphine, placebo and EMBEDA in either of the 6 sequences in the treatment phase of the study.'}, {'id': 'FG002', 'title': 'Placebo Then Morphine', 'description': 'Single dose of matching placebo solution orally on Day 1 followed by single dose of morphine sulfate 120 mg solution orally on Day 2. Participants in this group were assigned to morphine, placebo and EMBEDA in either of the 6 sequences in the treatment phase of the study.'}, {'id': 'FG003', 'title': 'Placebo Then EMBEDA Then Morphine', 'description': 'Single dose of matching placebo solution orally in first intervention period; followed by single dose of solution of EMBEDA extended release (ER) capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in second intervention period; then single dose of solution of morphine sulfate (MS Contin) controlled release (CR) tablet 120 mg orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.'}, {'id': 'FG004', 'title': 'EMBEDA Then Morphine Then Placebo', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in first intervention period; followed by single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in second intervention period; then single dose of matching placebo solution orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.'}, {'id': 'FG005', 'title': 'Morphine Then Placebo Then EMBEDA', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in first intervention period; followed by single dose of matching placebo solution orally in second intervention period; then single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.'}, {'id': 'FG006', 'title': 'Morphine Then EMBEDA Then Placebo', 'description': 'Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in first intervention period; followed by single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in second intervention period; then single dose of matching placebo solution orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.'}, {'id': 'FG007', 'title': 'Placebo Then Morphine Then EMBEDA', 'description': 'Single dose of matching placebo solution orally in first intervention period; followed by single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in second intervention period; then single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.'}, {'id': 'FG008', 'title': 'EMBEDA Then Placebo Then Morphine', 'description': 'Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in first intervention period; followed by single dose of matching placebo solution orally in second intervention period; then single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in third intervention period. 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'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Discrimination failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Drug Discrimination Phase: Day 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Discrimination failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Positive urine drug screen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Backup participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Treatment Phase: First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Treatment Phase: Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Treatment Phase: Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Treatment Phase: Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Treatment Phase: Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes all participants enrolled in the study.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.7', 'spread': '4.52', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-26', 'studyFirstSubmitDate': '2011-06-22', 'resultsFirstSubmitDate': '2012-04-26', 'studyFirstSubmitQcDate': '2011-06-23', 'lastUpdatePostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-26', 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2).'}, {'measure': 'Drug Liking: Peak Effect (Emax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). Emax = Maximum observed score.'}, {'measure': 'High: Area Under Effect Curve (AUE) From 0-2 Hours', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2)."}, {'measure': 'High: Peak Effect (Emax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score."}], 'secondaryOutcomes': [{'measure': 'Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).'}, {'measure': 'Drug Liking: Area Under Effect Curve (AUE) From 0-4 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).'}, {'measure': 'Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).'}, {'measure': 'Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).'}, {'measure': 'Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).'}, {'measure': 'Drug Liking: Time to Maximum (Peak) Effect (TEmax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). TEmax = Time to maximum observed score.'}, {'measure': 'High: Area Under Effect Curve (AUE) From 0-1 Hour', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1)."}, {'measure': 'High: Area Under Effect Curve (AUE) From 0-4 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4)."}, {'measure': 'High: Area Under Effect Curve (AUE) From 0-8 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8)."}, {'measure': 'High: Area Under Effect Curve (AUE) From 0-12 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12)."}, {'measure': 'High: Area Under Effect Curve (AUE) From 0-24 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24)."}, {'measure': 'High: Time to Maximum (Peak) Effect (TEmax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score."}, {'measure': 'Good Effects: Area Under Effect Curve (AUE) From 0-1 Hour', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1)."}, {'measure': 'Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2)."}, {'measure': 'Good Effects: Area Under Effect Curve (AUE) From 0-4 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4)."}, {'measure': 'Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8)."}, {'measure': 'Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12)."}, {'measure': 'Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24)."}, {'measure': 'Good Effects: Peak Effect (Emax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score."}, {'measure': 'Good Effects: Time to Maximum (Peak) Effect (TEmax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score."}, {'measure': 'Any Effects: Area Under Effect Curve (AUE) From 0-1 Hour', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1)."}, {'measure': 'Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2)."}, {'measure': 'Any Effects: Area Under Effect Curve (AUE) From 0-4 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4)."}, {'measure': 'Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8)."}, {'measure': 'Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12)."}, {'measure': 'Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24)."}, {'measure': 'Any Effects: Peak Effect (Emax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score."}, {'measure': 'Any Effects: Time to Maximum (Peak) Effect (TEmax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score."}, {'measure': 'Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hour', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1)."}, {'measure': 'Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2)."}, {'measure': 'Bad Effects: Area Under Effect Curve (AUE) From 0-4 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4)."}, {'measure': 'Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8)."}, {'measure': 'Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12)."}, {'measure': 'Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24)."}, {'measure': 'Bad Effects: Peak Effect (Emax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score."}, {'measure': 'Bad Effects: Time to Maximum (Peak) Effect (TEmax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score."}, {'measure': 'Nausea: Area Under Effect Curve (AUE) From 0-1 Hour', 'timeFrame': 'Pre-dose, 0.5 and 1 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1)."}, {'measure': 'Nausea: Area Under Effect Curve (AUE) From 0-2 Hours', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2)."}, {'measure': 'Nausea: Area Under Effect Curve (AUE) From 0-4 Hours', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4)."}, {'measure': 'Nausea: Area Under Effect Curve (AUE) From 0-8 Hours', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8)."}, {'measure': 'Nausea: Area Under Effect Curve (AUE) From 0-12 Hours', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12)."}, {'measure': 'Nausea: Area Under Effect Curve (AUE) From 0-24 Hours', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24)."}, {'measure': 'Nausea: Peak Effect (Emax)', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score."}, {'measure': 'Nausea: Time to Maximum (Peak) Effect (TEmax)', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score."}, {'measure': 'Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1)."}, {'measure': 'Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2)."}, {'measure': 'Feel Sick: Area Under Effect Curve (AUE) From 0-4 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4)."}, {'measure': 'Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8)."}, {'measure': 'Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12)."}, {'measure': 'Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24)."}, {'measure': 'Feel Sick: Peak Effect (Emax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score."}, {'measure': 'Feel Sick: Time to Maximum (Peak) Effect (TEmax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score."}, {'measure': 'Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr(0-1)."}, {'measure': 'Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2)."}, {'measure': 'Sleepy: Area Under Effect Curve (AUE) From 0-4 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4)."}, {'measure': 'Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8)."}, {'measure': 'Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12)."}, {'measure': 'Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24)."}, {'measure': 'Sleepy: Peak Effect (Emax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score."}, {'measure': 'Sleepy: Time to Maximum (Peak) Effect (TEmax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score."}, {'measure': 'Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour', 'timeFrame': '0.5 and 1 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1)."}, {'measure': 'Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours', 'timeFrame': '0.5, 1, 1.5 and 2 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2)."}, {'measure': 'Dizzy: Area Under Effect Curve (AUE) From 0-4 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4)."}, {'measure': 'Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8)."}, {'measure': 'Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12)."}, {'measure': 'Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24)."}, {'measure': 'Dizzy: Peak Effect (Emax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score."}, {'measure': 'Dizzy: Time to Maximum (Peak) Effect (TEmax)', 'timeFrame': '0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': "Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score."}, {'measure': 'Overall Drug Liking Effect at 24 Hours', 'timeFrame': '24 hrs post dose', 'description': 'Overall drug liking VAS assesses the participant\'s global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm= "neither like nor dislike", and 100 mm= "strong liking").'}, {'measure': 'Take Drug Again Effect at 24 Hours', 'timeFrame': '24 hrs post dose', 'description': 'Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would").'}, {'measure': 'Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour', 'timeFrame': 'Pre-dose, 0.5 and 1 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).'}, {'measure': 'Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).'}, {'measure': 'Pupillometry: Area Under Effect Curve (AUE) From 0-4 Hours', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).'}, {'measure': 'Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).'}, {'measure': 'Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).'}, {'measure': 'Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).'}, {'measure': 'Pupillometry: Peak Effect (Emax)', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. Emax = Smallest post-dose pupil size.'}, {'measure': 'Pupillometry: Time to Maximum (Peak) Effect (TEmax)', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to smallest post-dose pupil size.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Morphine', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Morphine', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Morphine', 'timeFrame': 'Pre-dose, 0.5 and 1 hrs post-dose', 'description': 'AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Morphine', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose', 'description': 'AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Morphine', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': 'AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Morphine', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': 'AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Morphine', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': 'AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Morphine', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Morphine', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Naltrexone', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone', 'timeFrame': 'Pre-dose, 0.5 and 1 hrs post-dose', 'description': 'AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose', 'description': 'AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': 'AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': 'AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': 'AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone Metabolite (6-beta-naltrexol)', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Naltrexone Metabolite (6-beta-naltrexol)', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone Metabolite (6-beta-naltrexol)', 'timeFrame': 'Pre-dose, 0.5 and 1 hrs post-dose', 'description': 'AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone Metabolite (6-beta-naltrexol)', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose', 'description': 'AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone Metabolite (6-beta-naltrexol)', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose', 'description': 'AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone Metabolite (6-beta-naltrexol)', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose', 'description': 'AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone Metabolite (6-beta-naltrexol)', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose', 'description': 'AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone Metabolite (6-beta-naltrexol)', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone Metabolite (6-beta-naltrexol)', 'timeFrame': 'Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose', 'description': 'AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['abuse potential', 'abuse liability', 'recreational opioid use', 'morphine'], 'conditions': ['Nondependent Opioid Abuse, Episodic']}, 'referencesModule': {'references': [{'pmid': '23745947', 'type': 'DERIVED', 'citation': 'Setnik B, Sommerville K, Goli V, Han L, Webster L. Assessment of pharmacodynamic effects following oral administration of crushed morphine sulfate and naltrexone hydrochloride extended-release capsules compared with crushed morphine sulfate controlled-release tablets and placebo in nondependent recreational opioid users. Pain Med. 2013 Aug;14(8):1173-86. doi: 10.1111/pme.12148. Epub 2013 Jun 7.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=ALO-01-10-4005&StudyName=Abuse%20Potential%20of%20Orally%20Administered%20Crushed%20Embeda%20Compared%20to%20Crushed%20Controlled-Release%20Morphine%20and%20Placebo%20in%20Non-Dependent%20Recre', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the abuse potential of EMBEDA compared to controlled release morphine when crushed and taken orally by non-dependent recreational opioid users; secondary purposes include to determine the abuse potential of crushed EMBEDA relative to placebo and and to compare the pharmacokinetics and safety of crushed EMBEDA with crushed controlled-release morphine and crushed placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a recreational opioid user who is NOT physically dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria, and the Naloxone Challenge. A recreational opioid user is defined as recreationally abusing opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks prior to Visit 1.\n* Subject is in generally good health as determined by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG).\n\nExclusion Criteria:\n\n* Has a history or current diagnosis of substance dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.\n* Has participated in, is currently participating in, or is seeking treatment for substance- and/or alcohol-related disorders (excluding nicotine and caffeine).\n* History or presence of any clinically significant illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, musculoskeletal, or psychiatric) or any other condition, which in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.\n* Has a known allergy or history of hypersensitivity to morphine sulfate, opioids in general, naltrexone hydrochloride (HCl) or similar compounds and/or the known excipients in the investigational drug products.\n* Has any condition in which an opioid is contraindicated (e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus).\n* Females who are pregnant, lactating, or are planning to become pregnant during the course of the study. Females with a positive serum pregnancy test at Visit 1 or at any subsequent study visit will be excluded from participating in the study.'}, 'identificationModule': {'nctId': 'NCT01380093', 'briefTitle': 'Abuse Potential of Orally Administered Crushed Embeda Compared to Crushed Controlled-Release Morphine and Placebo in Non-Dependent Recreational Opioid Users', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Way Crossover Study to Determine the Abuse Potential of Oral Administration of Crushed EMBEDA Relative to Crushed Controlled-Release Morphine Sulfate and Placebo in Non Dependent, Recreational Opioid Users', 'orgStudyIdInfo': {'id': 'ALO-01-10-4005'}, 'secondaryIdInfos': [{'id': 'B4541003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MS Contin (morphine sulfate, controlled release)', 'interventionNames': ['Drug: MS Contin (morphine sulfate, controlled release)']}, {'type': 'EXPERIMENTAL', 'label': 'EMBEDA (morphine sulfate / naltrexone hydrochloride)', 'interventionNames': ['Drug: EMBEDA (morphine sulfate / naltrexone hydrochloride)']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Single-dose, 2 x microcrystalline cellulose (weighed to equal weights of average tablet/capsule of active comparator) mixed with 150 ml artificially sweetened, non-carbonated beverage', 'armGroupLabels': ['Placebo']}, {'name': 'MS Contin (morphine sulfate, controlled release)', 'type': 'DRUG', 'description': 'Single-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage', 'armGroupLabels': ['MS Contin (morphine sulfate, controlled release)']}, {'name': 'EMBEDA (morphine sulfate / naltrexone hydrochloride)', 'type': 'DRUG', 'description': 'Single-dose, solution 2 x 60 mg morphine sulfate with sequestered 2.4 mg Naltrexone hydrochloride whole capsules manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage', 'armGroupLabels': ['EMBEDA (morphine sulfate / naltrexone hydrochloride)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Lifetree Clinical Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}