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This will be a randomized controlled trial to determine if postoperative ibuprofen after arthroscopic rotator cuff repair impacts postoperative opiate medication use, Visual Analog Scale (VAS) pain scores, shoulder range of motion (ROM), and repair integrity.
Patients will be randomized into two cohorts:
Patients will be screened for the study at the preoperative clinic vist and randomized on the day of surgery if they meet our inclusion criteria.
Postoperatively, they will be seen at 1 week, 6 weeks, 3 months, 6 months, 1 year, and 2 years. Pill counting will be done at the 1 week postoperative visit. VAS pain scores will be assessed at every visit. Functional shoulder outcomes including shoulder range of motion and the American Shoulder and Elbow Society (ASES) survey will be completed at these visits as well. The SF-12 health and Disabilities of Arm, Shoulder, and Hand (DASH) survey will be completed at the preoperative visit and final follow-up visit only. We will assess rotator cuff repair integrity with ultrasound study at 1 year after surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. |
|
| Placebo | Placebo Comparator | Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator. |
| Measure | Description | Time Frame |
|---|---|---|
| Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo | pain control | 1 week post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | American Shoulder Elbow Surgery Score (ASES) - This is a patient reported outcomes score based on a series of questions. The ASES is a 100-point scale that consists of two subscores -- activity of daily living (ADL) and pain visual analog scale (VAS) -- but is reported as one overall score. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. The minimum score is 0 and the maximum score is 100. The higher the score, the better the outcome, indicating better shoulder function (i.e., less pain and better ability to perform daily activities). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C. Benjamin Ma, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Orthopaedic Institute | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15276196 | Background | Gilson AM, Ryan KM, Joranson DE, Dahl JL. A reassessment of trends in the medical use and abuse of opioid analgesics and implications for diversion control: 1997-2002. J Pain Symptom Manage. 2004 Aug;28(2):176-88. doi: 10.1016/j.jpainsymman.2004.01.003. | |
| 23302898 | Background | Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen | Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator. |
| FG001 | Placebo | Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
110 patients were originally enrolled in the studied however 9 were dropped or elected to withdrawal and did not complete the study medication. Their baseline characteristics were excluded from the analysis because of violation of the protocol or because the patient requested to not have their information as part of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen | Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opiate Consumption in Patients Prescribed Ibuprofen Versus Placebo | pain control | Posted | Mean | Standard Deviation | morphine milligram equivalents | 1 week post operative |
|
Data collected for up to 1 year postop
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibuprofen | Ibuprofen 400mg by mouth three times daily. Patients will also receive the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Ibuprofen: Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Tangtiphaiboontana | University of California, San Francisco | 5622095440 | Jennifer.Tangtiphaiboontana@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2015 | Oct 6, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 16, 2019 | Oct 6, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000070656 | Rotator Cuff Tear Arthropathy |
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
|
| Placebo | Drug | Pharmacy formulated placebo |
|
| Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op |
| Assessment of Functional Shoulder Outcome Score: DASH | The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. A lower score means a better outcome | preop, 1 year postop |
| Assessment of Functional Shoulder Outcome Score: SF-12 | The SF-12 (12-item short form health survey) is a general HRQoL survey that measures general health status in 8 domains (physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Each score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning. | Preop, 1 year post/op |
| Post Operative Pain Score (Visual Analog Scale) | Pain scale from 0 (no pain) - 10 (worst) | 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op |
| Range of Motion - Forward Flexion | Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees | Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op |
| Range of Motion - Abduction | Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees | preoperative, 6 weeks, 3 months, 6 months, 1 year |
| Range of Motion - External Rotation at Side | Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees | preoperative, 6 weeks, 3 months, 6 months, 1 year |
| Range of Motion - External Rotation at 90 Degrees Abduction | Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees | preoperative, 6 weeks, 3 months, 6 months, 1 year |
| 2064886 | Background | Dahl JB, Kehlet H. Non-steroidal anti-inflammatory drugs: rationale for use in severe postoperative pain. Br J Anaesth. 1991 Jun;66(6):703-12. doi: 10.1093/bja/66.6.703. No abstract available. |
| 15161166 | Background | Dahners LE, Mullis BH. Effects of nonsteroidal anti-inflammatory drugs on bone formation and soft-tissue healing. J Am Acad Orthop Surg. 2004 May-Jun;12(3):139-43. doi: 10.5435/00124635-200405000-00001. |
| 16210573 | Background | Cohen DB, Kawamura S, Ehteshami JR, Rodeo SA. Indomethacin and celecoxib impair rotator cuff tendon-to-bone healing. Am J Sports Med. 2006 Mar;34(3):362-9. doi: 10.1177/0363546505280428. Epub 2005 Oct 6. |
| 25436192 | Background | Rouhani A, Tabrizi A, Elmi A, Abedini N, Mirza Tolouei F. Effects of preoperative non-steroidal anti-inflammatory drugs on pain mitigation and patients' shoulder performance following rotator cuff repair. Adv Pharm Bull. 2014 Dec;4(4):363-7. doi: 10.5681/apb.2014.053. Epub 2014 Aug 10. |
| 19535272 | Background | Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):927-32. doi: 10.1016/j.jse.2009.03.021. Epub 2009 Jun 16. |
| 23206691 | Background | van der Zwaal P, Thomassen BJ, Nieuwenhuijse MJ, Lindenburg R, Swen JW, van Arkel ER. Clinical outcome in all-arthroscopic versus mini-open rotator cuff repair in small to medium-sized tears: a randomized controlled trial in 100 patients with 1-year follow-up. Arthroscopy. 2013 Feb;29(2):266-73. doi: 10.1016/j.arthro.2012.08.022. Epub 2012 Dec 1. |
| BG001 | Placebo | Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Preoperative NSAID Use | Count of Participants | Participants |
|
| Preoperative Opioid Use | Count of Participants | Participants |
|
| Prior Shoulder Cortisone Injection | Count of Participants | Participants |
|
| Shoulder Involved | Count of Participants | Participants |
|
| Hand Dominance | Data missing as some patient's did not answer questions regarding hand dominance | Count of Participants | Participants |
|
| Surgical Side | Some patients did not answer the question regarding hand dominance therefore there are missing data points | Count of Participants | Participants |
|
| Size of Rotator Cuff Tear | One patient in the ibuprofen group did not have their tear size categorized by the treating surgeon therefore data point is missing | Count of Participants | Participants |
|
| Tendons Torn | Count of Participants | Participants |
|
| Biceps Tenotomy | Biceps Tenotomy is an additional procedure often performed at the time of rotator cuff surgery if patients have biceps pathology or pain. Documentation of whether not the procedure was performed was based on the surgeon's report and operative note. | Count of Participants | Participants |
|
| Repair Technique | Single Row and Double Row are surgical repair techniques. | repair techniques were not document by the treating surgeon for 5 patients in the ibuprofen group and 3 patients in the placebo group therefore these data points are missing | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo |
|
|
| Secondary | Assessment of Functional Shoulder Outcome Score: American Shoulder Elbow Surgery Score (ASES) | American Shoulder Elbow Surgery Score (ASES) - This is a patient reported outcomes score based on a series of questions. The ASES is a 100-point scale that consists of two subscores -- activity of daily living (ADL) and pain visual analog scale (VAS) -- but is reported as one overall score. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. The minimum score is 0 and the maximum score is 100. The higher the score, the better the outcome, indicating better shoulder function (i.e., less pain and better ability to perform daily activities). | The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful | Posted | Mean | Standard Deviation | score on a scale | Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op |
|
|
|
| Secondary | Assessment of Functional Shoulder Outcome Score: DASH | The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. A lower score means a better outcome | The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful | Posted | Mean | Standard Deviation | score on a scale | preop, 1 year postop |
|
|
|
| Secondary | Assessment of Functional Shoulder Outcome Score: SF-12 | The SF-12 (12-item short form health survey) is a general HRQoL survey that measures general health status in 8 domains (physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Each score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning. | The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful | Posted | Mean | Standard Deviation | score on a scale | Preop, 1 year post/op |
|
|
|
| Secondary | Post Operative Pain Score (Visual Analog Scale) | Pain scale from 0 (no pain) - 10 (worst) | The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful | Posted | Mean | Standard Deviation | score on a scale | 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op |
|
|
|
| Secondary | Range of Motion - Forward Flexion | Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees | The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful | Posted | Mean | Standard Deviation | degrees | Preop, 6-weeks post/op, 3 months post/op, 6 months post/op, 1 year post/op |
|
|
|
| Secondary | Range of Motion - Abduction | Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees | The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful | Posted | Mean | Standard Deviation | degrees | preoperative, 6 weeks, 3 months, 6 months, 1 year |
|
|
|
| Secondary | Range of Motion - External Rotation at Side | Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees | The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful | Posted | Mean | Standard Deviation | degrees | preoperative, 6 weeks, 3 months, 6 months, 1 year |
|
|
|
| Secondary | Range of Motion - External Rotation at 90 Degrees Abduction | Shoulder motion measured in clinic by a consistent study coordinator/assistant who was blinded to the randomization group using a goniometer. Measurements documented in degrees | The number of patients analyzed at the different times points vary from row to row and do not match the overall number of patients in the study due to lost to follow-up of patients over course of study. Several attempts through various means (ie: phone call, email, mail, etc) to reach patients to collect the data were unsuccessful | Posted | Mean | Standard Deviation | degrees | preoperative, 6 weeks, 3 months, 6 months, 1 year |
|
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| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Placebo | Placebo tablet by mouth three times daily. Patients will also received the standard opiate medication (hydrocodone/acetaminophen 10mg/325mg) for the UCSF orthopaedic clinic for postoperative pain control. Placebo: Pharmacy formulated placebo | 0 | 54 | 0 | 54 | 0 | 54 |
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| D000070657 |
| Crystal Arthropathies |
| 6 weeks |
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| 3 months |
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| 6 months |
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| 1 year |
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| 1 year |
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| SF-12 PCS 1 year |
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| SF-12 MCS preoperative |
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| Sf-12 MCS 1 year |
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| 3 months |
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| 6 months |
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| 1 year |
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| 6 weeks |
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| 3 months |
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| 6 months |
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| 1 year |
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| 6 weeks |
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| 3 months |
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| 6 months |
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| 1 year |
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| 6 weeks |
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| 3 months |
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| 6 months |
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| 1 year |
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| 6 weeks |
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| 3 months |
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| 6 months |
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| 1 year |
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