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kzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
Study to investigate the analgesic efficacy of a single dose of AZD1940
Study identifier:D3120C00006
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Double Blind, Placebo-Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940, in Patients Undergoing Impacted Mandibular Third Molar Extraction
Medical condition
Pain
Phase
Phase 2
Healthy volunteers
Yes
Study drug
AZD1940, Naproxen, Placebo
Sex
All
Actual Enrollment
151
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Feb 2008
Primary Completion Date: 01 May 2008
Study Completion Date: 01 May 2008
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 May 2010 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Location
Research Site
Salt Lake City, UT, United States
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD1940 AZD1940 800ug given predose | Drug: AZD1940 800ug oral administration |
| Active Comparator: Naproxen Naproxen 500mg given pre-surgery | Drug: Naproxen 500mg oral administration Other Name: Naprosyn |
| Placebo Comparator: Placebo Placebo given pre-surgery | Drug: Placebo Placebo given pre-surgery |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 1 centre (Lifetree Clinical Research, Salt Lake City, Utah, USA) recruited between Feb and May 2008 |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Screening for eligibility |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Participant Flow: Overall Study
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
| STARTED | 61 | 59 | 31 |
| COMPLETED | 59 | 59 | 30 |
| NOT COMPLETED | 2 | 0 | 1 |
| Lost to Follow-up | 2 | 0 | 1 |
Baseline Characteristics
Analysis Population Description -- Explanation of how the number of participants for analysis was determined.
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Baseline Measures
| AZD1940 | Placebo | Naproxen | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: Participants] |
61 | 59 | 31 | 151 |
| Age Continuous [units: Years] Mean ( Full Range ) |
20.6 (18 to 35) | 21.0 (18 to 39) | 20.5 (18 to 35) | 20.7 (18 to 39) |
| Gender, Customized [units: Participants] |
61 | 59 | 31 | 151 |
Outcome Measures
1. Primary Outcome Measure: Pain Area Under the Curve 0-8h (AUC0-8h) [ Time Frame: 0-8 h(from end of surgery to 8 hours post surgery) ]
| Measure Type | Primary |
|---|---|
| Measure Name | Pain Area Under the Curve 0-8h (AUC0-8h) |
| Measure Description | Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. |
| Time Frame | 0-8 h(from end of surgery to 8 hours post surgery) |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analyses based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
61 | 59 | 31 |
| Pain Area Under the Curve 0-8h (AUC0-8h) [units: mm*h] Mean (Standard Deviation) |
355 (182.3) | 356 (165.7) | 129 (105.4) |
No statistical analysis provided for Pain Area Under the Curve 0-8h (AUC0-8h)
2. Secondary Outcome Measure: Pain Area Under the VAS versus time curve 0-4h (AUC0-4h) [ Time Frame: 0-4h (from end of surgery to 4 hours post surgery) ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Pain Area Under the VAS versus time curve 0-4h (AUC0-4h) |
| Measure Description | Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. |
| Time Frame | 0-4h (from end of surgery to 4 hours post surgery) |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analyses based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
61 | 59 | 31 |
| Pain Area Under the VAS versus time curve 0-4h (AUC0-4h) [units: mm*h] Mean (Standard Deviation) |
145 (93.5) | 143 (81.7) | 54 (45.0) |
No statistical analysis provided for Pain Area Under the VAS versus time curve 0-4h (AUC0-4h)
3. Secondary Outcome Measure: Maximum pain based on VAS scale [ Time Frame: From end of surgery to 8h or time first intake of rescue medication (whichever came first) ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Maximum pain based on VAS scale |
| Measure Description | Maximum pain recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case. Maximum pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable) |
| Time Frame | From end of surgery to 8h or time first intake of rescue medication (whichever came first) |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analyses based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
61 | 59 | 31 |
| Maximum pain based on VAS scale [units: mm] Mean (Standard Deviation) |
66 (24.5) | 65 (23.7) | 33 (20.7) |
No statistical analysis provided for Maximum pain based on VAS scale
4. Secondary Outcome Measure: Mean pain based on a VAS scale [ Time Frame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first) ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Mean pain based on a VAS scale |
| Measure Description | Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) versus time curve divided by time.Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable) |
| Time Frame | From end of surgery to 8h or time to first intake of rescue medication (whichever came first) |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analyses based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
61 | 59 | 31 |
| Mean pain based on a VAS scale [units: mm] Mean (Standard Deviation) |
31 (19.0) | 29 (16.7) | 13 (10.6) |
No statistical analysis provided for Mean pain based on a VAS scale
5. Secondary Outcome Measure: Pain at jaw movement AUC0-8h [ Time Frame: 0-8h from end of surgery to 8 hours post surgery ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Pain at jaw movement AUC0-8h |
| Measure Description | Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-8h (from end of surgery) of VAS pain at jaw movement (0-100mm, 0 = no pain - 100 = worst pain imaginable) |
| Time Frame | 0-8h from end of surgery to 8 hours post surgery |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analyses based on a per-protocol pop. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
61 | 59 | 31 |
| Pain at jaw movement AUC0-8h [units: mm*h] Mean (Standard Deviation) |
342 (192.0) | 337 (170.5) | 135 (119.7) |
No statistical analysis provided for Pain at jaw movement AUC0-8h
6. Secondary Outcome Measure: Pain at jaw movement AUC0-4h [ Time Frame: 0-4h after end of surgery to 4 hours post surgery ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Pain at jaw movement AUC0-4h |
| Measure Description | Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-4h (from end of surgery) of VAS pain at jaw movement (0-100mm0 = no pain - 100 = worst pain imaginable). |
| Time Frame | 0-4h after end of surgery to 4 hours post surgery |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analyses based on a per-protocol pop. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
61 | 59 | 31 |
| Pain at jaw movement AUC0-4h [units: mm*h] Mean (Standard Deviation) |
142 (100.3) | 138 (86.9) | 53 (47.5) |
No statistical analysis provided for Pain at jaw movement AUC0-4h
7. Secondary Outcome Measure: Maximum pain at jaw movement [ Time Frame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first) ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Maximum pain at jaw movement |
| Measure Description | Maximum pain at jaw movement recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case. Maximum Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable) |
| Time Frame | From end of surgery to 8h or time to first intake of rescue medication (whichever came first) |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analyses based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
61 | 59 | 31 |
| Maximum pain at jaw movement [units: mm] Mean (Standard Deviation) |
63 (25.2) | 63 (25.5) | 33 (24.7) |
No statistical analysis provided for Maximum pain at jaw movement
8. Secondary Outcome Measure: Mean pain at jaw movement [ Time Frame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first) ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Mean pain at jaw movement |
| Measure Description | Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) of jaw movement versus time curve divided by time. Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable ). |
| Time Frame | From end of surgery to 8h or time to first intake of rescue medication (whichever came first) |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analyses based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
61 | 59 | 31 |
| Mean pain at jaw movement [units: mm] Mean (Standard Deviation) |
32 (20.9) | 28 (16.9) | 14 (12.4) |
No statistical analysis provided for Mean pain at jaw movement
9. Secondary Outcome Measure: Pain at rescue medication [ Time Frame: At time of first rescue medication taken before 8 hours after end of surgery ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Pain at rescue medication |
| Measure Description | Pain at time of first rescue medication (VAS 0-100mm). Only patients taking rescue are included in analysis. Observed case. Pain at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable). |
| Time Frame | At time of first rescue medication taken before 8 hours after end of surgery |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
37 | 43 | 7 |
| Pain at rescue medication [units: mm] Mean (Standard Deviation) |
73 (20.6) | 70 (20.5) | 47 (13.8) |
No statistical analysis provided for Pain at rescue medication
10. Secondary Outcome Measure: Pain at jaw movement at time of first rescue medication [ Time Frame: At time of first rescue medication (before 8 hours after end on surgery) ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Pain at jaw movement at time of first rescue medication |
| Measure Description | Pain at jaw movement at time of first rescue medication (VAS 0-100mm). Observed case. Pain at jaw movement at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable). |
| Time Frame | At time of first rescue medication (before 8 hours after end on surgery) |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
37 | 43 | 7 |
| Pain at jaw movement at time of first rescue medication [units: mm] Mean (Standard Deviation) |
67 (26.2) | 65 (25.5) | 53 (15.4) |
No statistical analysis provided for Pain at jaw movement at time of first rescue medication
11. Secondary Outcome Measure: Time to first intake of rescue medication. [ Time Frame: From end of surgery to 8 hours following surgery ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Time to first intake of rescue medication. |
| Measure Description | |
| Time Frame | From end of surgery to 8 hours following surgery |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients actually taking rescue medication are included in analysis. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
37 | 43 | 7 |
| Time to first intake of rescue medication. [units: Hours] Mean (Standard Deviation) |
3.8 (1.05) | 3.7 (1.16) | 4.7 (1.18) |
No statistical analysis provided for Time to first intake of rescue medication.
12. Secondary Outcome Measure: Number of patients requesting rescue medication [ Time Frame: End of surgery up to 8hours following surgery ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Number of patients requesting rescue medication |
| Measure Description | Observed case. |
| Time Frame | End of surgery up to 8hours following surgery |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
61 | 59 | 31 |
| Number of patients requesting rescue medication [units: Participants] |
37 | 43 | 7 |
No statistical analysis provided for Number of patients requesting rescue medication
13. Secondary Outcome Measure: Maximum deterioration in Visual Analogue Mood Scale (VAMS) Stimulated [ Time Frame: Between dosing and 12h post-dose ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Maximum deterioration in Visual Analogue Mood Scale (VAMS) Stimulated |
| Measure Description | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. |
| Time Frame | Between dosing and 12h post-dose |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
41 | 12 | 28 |
| Maximum deterioration in Visual Analogue Mood Scale (VAMS) Stimulated [units: mm] Mean (Standard Deviation) |
22 (15.1) | 26 (23.9) | 28 (22.7) |
No statistical analysis provided for Maximum deterioration in Visual Analogue Mood Scale (VAMS) Stimulated
14. Secondary Outcome Measure: Maximum deterioration in VAMS High [ Time Frame: Between dosing and 12h post-dose ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Maximum deterioration in VAMS High |
| Measure Description | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. |
| Time Frame | Between dosing and 12h post-dose |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
41 | 16 | 10 |
| Maximum deterioration in VAMS High [units: mm] Mean (Standard Deviation) |
30 (25.2) | 12 (7.5) | 20 (22.8) |
No statistical analysis provided for Maximum deterioration in VAMS High
15. Secondary Outcome Measure: Maximum deterioration in VAMS Anxious [ Time Frame: Between dosing and 12h post-dose ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Maximum deterioration in VAMS Anxious |
| Measure Description | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. |
| Time Frame | Between dosing and 12h post-dose |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
35 | 27 | 13 |
| Maximum deterioration in VAMS Anxious [units: mm] Mean (Standard Deviation) |
20 (20.0) | 15 (13.1) | 13 (15.1) |
No statistical analysis provided for Maximum deterioration in VAMS Anxious
16. Secondary Outcome Measure: Maximum deterioration in VAMS Sedated [ Time Frame: Between dosing and 12h post-dose ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Maximum deterioration in VAMS Sedated |
| Measure Description | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. |
| Time Frame | Between dosing and 12h post-dose |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
53 | 33 | 12 |
| Maximum deterioration in VAMS Sedated [units: mm] Mean (Standard Deviation) |
33 (24.8) | 21 (19.2) | 24 (26.4) |
No statistical analysis provided for Maximum deterioration in VAMS Sedated
17. Secondary Outcome Measure: Maximum deterioration in VAMS Down [ Time Frame: Between dosing and 12h post-dose ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Maximum deterioration in VAMS Down |
| Measure Description | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. |
| Time Frame | Between dosing and 12h post-dose |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients reporting a deterioration are included. The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
32 | 22 | 8 |
| Maximum deterioration in VAMS Down [units: mm] Mean (Standard Deviation) |
20 (20.4) | 25 (23.5) | 24 (29.0) |
No statistical analysis provided for Maximum deterioration in VAMS Down
18. Secondary Outcome Measure: Time to max deterioration in VAMS Stimulated [ Time Frame: Between dosing and 12h post-dose ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Time to max deterioration in VAMS Stimulated |
| Measure Description | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. |
| Time Frame | Between dosing and 12h post-dose |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
41 | 28 | 12 |
| Time to max deterioration in VAMS Stimulated [units: Minutes] Mean (Standard Deviation) |
143 (94.9) | 163 (108) | 213 (190) |
No statistical analysis provided for Time to max deterioration in VAMS Stimulated
19. Secondary Outcome Measure: Time to max deterioration in VAMS High [ Time Frame: Between dosing and 12h post-dose ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Time to max deterioration in VAMS High |
| Measure Description | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. |
| Time Frame | Between dosing and 12h post-dose |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
41 | 16 | 10 |
| Time to max deterioration in VAMS High [units: minutes] Mean (Standard Deviation) |
115 (56.7) | 191 (180.0) | 193 (125.9) |
No statistical analysis provided for Time to max deterioration in VAMS High
20. Secondary Outcome Measure: Time to max deterioration in VAMS Anxious [ Time Frame: Between dosing and 12h post-dose ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Time to max deterioration in VAMS Anxious |
| Measure Description | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. |
| Time Frame | Between dosing and 12h post-dose |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
35 | 27 | 13 |
| Time to max deterioration in VAMS Anxious [units: minutes] Mean (Standard Deviation) |
126 (88.0) | 167 (115.7) | 212 (207.2) |
No statistical analysis provided for Time to max deterioration in VAMS Anxious
21. Secondary Outcome Measure: Time to max deterioration in VAMS Sedated [ Time Frame: Between dosing and 12h post-dose ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Time to max deterioration in VAMS Sedated |
| Measure Description | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. |
| Time Frame | Between dosing and 12h post-dose |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
53 | 33 | 12 |
| Time to max deterioration in VAMS Sedated [units: minutes] Mean (Standard Deviation) |
190 (134.7) | 221 (134.5) | 227 (150.5) |
No statistical analysis provided for Time to max deterioration in VAMS Sedated
22. Secondary Outcome Measure: Time to max deterioration in VAMS Down [ Time Frame: Between dosing and 12h post-dose ]
| Measure Type | Secondary |
|---|---|
| Measure Name | Time to max deterioration in VAMS Down |
| Measure Description | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. |
| Time Frame | Between dosing and 12h post-dose |
| Safety Issue? | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Measured Values
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
|
Number of
Participants Analyzed [units:participants] |
32 | 22 | 8 |
| Time to max deterioration in VAMS Down [units: minutes] Mean (Standard Deviation) |
227 (156.2) | 262 (106.3) | 349 (243.3) |
No statistical analysis provided for Time to max deterioration in VAMS Down
Serious Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Serious Adverse Events
| AZD1940 | Placebo | Naproxen | |
|---|---|---|---|
| Total, serious adverse events | |||
| # participants affected / at risk | 0/61 (0.00%) | 0/59 (0.00%) | 0/31 (0.00%) |
Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 0% |
|---|
Reporting Groups
| Description | |
|---|---|
| AZD1940 | AZD1940 800ug given predose |
| Placebo | Placebo given pre-surgery |
| Naproxen | Naproxen 500mg given pre-surgery |
Other Adverse Events
| AZD1940 | Placebo | Naproxen | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total, other (not including serious) adverse events | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 3/61 (4.92%) | 2/59 (3.39%) | 0/31 (0.00%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Nervous system disorders | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Presyncope, Syncope1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| # participants affected / at risk | 3/61 (4.92%) | 2/59 (3.39%) | 0/31 (0.00%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Certain Agreements
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact
| Name/Title: | Gerard Lynch |
| Organization: | AstraZeneca |
| E-mail: | [email protected] |
Contacts
Investigators
Principal Investigator
Lynn Webster
Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA
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hOOU56EiQQwzYiEgvA%2F1WSUkzNJdSnkXHe%2FW9pk7hECC%2BwL93HtqZoHMhhQFTXb15o5kBPRqpoKMYKle3oENsCgSj17p6aTD3gyYNEAhFrk4AnaHTn0kRFHH7dlMdIwGDIdC5YsdhoIP14dLI1b2D70lykG2HbUWNfpakw%2F9%2FxngpaHGqJ7E3sLaXwBMAfYo7i0T4TpG8mit82Njb5gTpBtI5ABFrHAri9BbKAh2pBnjtWL93xeFg2DlvO5JPMqTCXBFrT4xf0ikKOlLqDNtxGOhIdfnsmvLvKD9nOugYNsWrYybQkTwy3Y7XVGHQPHL4aPO6DDqGOh6h4S5uqxn7YQuiuQC0cYf5iNS59WuBjlU3JzJg%2Fk7oxGsMBvedzM%2Bx%2BjM33VVJJyrWBi64XxP6lmX5qmXaft9OCx7I6ILOFTsOJ57ilsXY3PwhZ8GxWV%2FdQr0ykoxPFSdnc0BNF%2BQU3Qx0OhHO8vDExgZPUBS4TKe5BDoXAEdV2c%2FkdFm8cwCdE2kFPb48FV3ZRFKKI9BSIUjtOlwidg%2FQ6QDOmsBoJe8pKqVXf1aTTsJ2HAE6UhoJu5%2B9k%2BYWoKOoXdM8Oso6TKFFB3CwDwDw4A8A9SEQ0wvC9dZArLUWOOo1AfDDIehdWwye5PanQ%2BkKryMNdKTHAHrdiGFV3gYYitdw9GIeRclfPbR9a9CxKqxZ%2BSyCGaQtwQQQEYVNzZxWA3o5dB6TeL%2FfEHRMl7c3pgA%2FwShOz5S4GIX30H7I6zMLdE5KOKOhCFCzgBNcdfyklPK3yLrsQGckNsdq3AuZjwxKe8c4RQ6u2TuAjpbv5F7b2k7uUBClUZBr2I4j6ai4vIeN5sbaTLfpNHpJWofjihzQ0VzmQ%2B54gw7S8B0yL7S5quEII%2FvFuKyv14SZZxbpV9lrIeCRoCOjTodPVkMXn8Xcbp7XHUBHnr5hdUc5zSz9WcvAn7EphpNzg8x3K9CR%2FDh0IjvAIzd5eB2DwIvXQuEXRlrLkE3HOKh6JNgSlJkLH141cuXjW5Jkftka4i5%2Bepf38UMp5Q2PZyToDMXmdKQdydyXFpT6iUQ%2B3wF05GnmGoPbSaa5rA90MVycs%2Bh3%2BVAJbrjwCd9oY7nMZa2gUzZCY8xwI3Oj%2FqW2DbU7BByGWhb6lu2NUe8k2ZUi7nsPR%2Bj3z0spf%2FRe3kBHIdppPVfJpzlITCwbt0aqsDXmdE%2B%2BO4COBGZ3g3VOoUgS4rC02TkMwGC8%2FhFeRTmOQ0kRRTWjUhWH8rG3sum0NZcHWOhub0rEtQJMDVPCSNuwCUHyWmlnSCuudNq5zncUdLQof2%2F%2Fz%2Fw9VEsHHXLQ6dbNGRmdoWKtC9D0TizYUO6VYdM5LIwCOp6HaAcinstcibwGaUxbQxu3rMFC5JSgczkex1sn5UBQC1HxdhTayxoyN1GvOhKit6bS0InxIrdql1xrrKVX9At8ixQKUj22ioqKzcyrLogQEbkXiPQh1YxJOlJd9Fhh1u%2FwyIGP3etvqMMVdHogcXZkSmLipo8bl8QD9MAUO5diOwm0FHxVvzdqpCCMG8wC3RS4skVojgYHdoLWaPy8MhzFHhEZsTC8bskmJd0oGI76lTVqtFPxEPDVqf8swfJmoNP4U3r98N9qdKwR8m%2Fd3wSe4LVx%2BDrtNlKjBeYJe5ssErc6Ejp3kIOvSZokPgTgEC%2BAZ2Bj4bzhSkniYLgn6ICPEX%2B2xmmNYgSBjtQHL8ctKJZ0npVsLXZ0%2FIiGVK8y7dxCSm13ayR7ko6h5kXGjcA2bBRew4WXcdBqHUfajbwjQadHf6q0yI2GvI8D2N9SvWInuQY8%2BJk2LM9l4uPtFilzJFG0w0vPSvvHQZIxDtTeGq2SZivFOhQ4KkBH2qgifBF9B2MEaAJokI5kFnyLNEigc4jNQWJcpAHrHaNolWR%2BMBKSIKOh4m7hoIAV%2FzLoNOCxYockSTa3pCJR8uTGu4FOYCNry2rS%2Fh6gM0hzGn8oRqYjTfW2gNm2obZpbW11aZTDcshTF4yEjm5pSrrG35BmTqU7WJ0Vdicxf%2Bd0gR6BvgAVJLvRs6tP3BabClRDFeF3DdE3VHw7jLIsZBvqFNe90RakC34FDewt2wnWqwMkiciM4dsVNe0dGvOurzbfXX%2FNkAvRHOPkAWtRBom8t5XTNOZgpaCQFAF6QbpUT7imAvPiYId17g2ySQfbens3irBSsbwOM76n1BOznK0zDuJFuZ6cF1dVyVMr2nri4Ab%2Fk9TIU2N2bbA8PurrK9w7FVlcdoigH%2FRJe8n7HHwq0zFwEF6SZLxO3cLsXgP5%2B%2BtFARazAXX4psw3g3JsvDDWTT2RedvtIr%2BHpwcDIEofouqARBtSn59sff8H57piU0311KcAAAAASUVORK5CYII%3D%22%2F%3E%0A%3C%2Fdefs%3E%0A%3C%2Fsvg%3E%0A)
