Comparative Analysis of Outcomes Among Patients Treated With Xeljanz vs Biologics

Arthritis, Rheumatoid Clinical Trial

Official title:

Comparative Analysis of Outcomes Among Rheumatoid Arthritis Patients Treated With Xeljanz Versus Biologic DMARDs Using a United States Healthcare Claims Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964649
• Other study ID #: A3921305
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: April 6, 2020

Study information

• Verified date: May 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare rheumatoid arthritis (RA) patient characteristics, adherence, and costs between patients treated with tofacitinib (IR, XR and combined groups) to patients treated with each of the bDMARDs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7308
• Est. completion date: April 6, 2020
• Est. primary completion date: April 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• At least one claim for methotrexate during the variable-length pre-index period.
• At least one claim for tofacitinib or bDMARDs between 01 February 2016 and 31 July 2019 (the identification period).

Exclusion Criteria:

• Patients with claims for other conditions for which bDMARDs are used during the one-year pre-index period or on the index date: ankylosing spondylitis, Crohn's disease, psoriasis, psoriatic arthritis, or ulcerative colitis will be excluded from the study.
• Patients with evidence of the index medication during the one-year pre-index period will be removed from the analysis. Patients will be allowed to have been treated with (other) bDMARDs during the one-year pre-index period.
• Patients with more than 1 bDMARD or bDMARD with tofacitinib filled on the index date will be removed from the study.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Locations

Country	Name	City	State
United States	Pfizer	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Were on Combination Therapy and Monotherapy During 90 Days After Index Date	In this outcome measure number of participants who were on combination therapy with index medication and who were on monotherapy during 12 months pre-index date were reported. Participants with a use of at least 1 of 4 specific csDMARDs (methotrexate, sulfasalazine, hydroxychloroquine, leflunomide) within 90 days on or after the index date were considered as being treated with combination therapy. Participants who did not take any csDMARDs along with index medication were considered being treated with monotherapy.	Within 90 days after index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Number of Participants for Each of the Most Commonly Used Medications During the 12 Months Post-index Date	Number of participants with most commonly used medications use during 12 months post index period are reported. The 25 most medications: 1) methotrexate sodium, 2) prednisone, 3) folic acid, 4) adalimumab, 5) etanercept, 6) acetaminophen/hydrocodone bitartrate, 7) hydroxychloroquine sulfate, 8) azithromycin, 9) levothyroxine sodium, 10) tramadol hydrochloride, 11) methylprednisolone, 12) gabapentin, 13) albuterol sulfate, 14) amoxicillin/clavulanate potassium, 15) omeprazole, 16) amoxicillin, 17) meloxicam, 18) tofacitinib citrate, 19) fluticasone propionate, 20) cyclobenzaprine hydrochloride, 21) diclofenac sodium, 22) duloxetine hydrochloride, 23) atorvastatin calcium, 24) leflunomide, 25) fluconazole. A participant could have received >=1 most common medication.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Number of Participants Who Used Opioids and Non-steroidal Anti-inflammatory Drug (NSAIDs) During 12 Months Post Index Period	Number of participants who used at least 1 opioid and NSAID during post-index period are reported.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Mean Number of Pharmacy Claims for Opioids and NSAIDS During 12 Months Post Index Period	The mean number of pharmacy claims for opioids and NSAIDs during the post-index period are reported. A pharmacy claim was defined as a claim made by participants to their insurance provider in purchasing opioids and NSAIDs from the pharmacy.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Mean Number of Days From The Index Date to the First Opioid and NSAIDs Claim During 12 Months Post Index Period	Mean number of days from the index date to the first opioid and NSAIDs claim during post index period are reported.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Number of Participants Who Used Opioids and NSAIDs While Persistent and After Persistent With Index Medication During 12 Months Post Index Period	Number of participants who used opioids and NSAIDs during tofacitinib persistency and post-persistency are reported. Persistence with the index medication was defined as not having a gap in therapy of at least 60 days between fills/infusions.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Number of Participants Who Used Oral Corticosteroids During 12 Months Post-Index Period	The number of participants who used at least 1 oral corticosteroid during the 12 months post-index period are reported.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Number of Participants Who Were Non-persistent to Index Medication	Non-persistence was defined as the gap of at least 60 days in treatment with the index medication or switching to other biologic.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Number of Participants Who Switched Immediately From Index Medication	Participants were classified as switched immediately if they initiated a non-index bDMARD before a 60-day gap in index medication treatment.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Number of Participants Who Discontinued Then Restarted Index Medication	Participants were classified as discontinued and then restarted index medication if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap was the index medication.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Number of Participants Who Discontinued Then Switched From Index Medication	Participants were classified as discontinued and then switched from index medication if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap was a bDMARD (including tofacitinib) different from index medication.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Number of Participants Who Discontinued Without Switching or Restarting Index Medication	Participants were classified as discontinued without switching or restarting index medication if they had a gap in therapy of at least 60 days and there were no claims for either the index medication or a different bDMARD for the remainder of the follow-up period.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Number of Participants Who Switched Any Time From Index Medication	Number of participants who switched from index medication to a biologic at any time during post-index period are reported.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Number of Participants Who Re-started Index Medication at Any Time	Participants who had a claim for the index medication any time after they were considered non-persistent with the index treatment (i.e, including after switching) during the 12-month follow-up are reported. Non-persistence was defined as the gap of at least 60 days in treatment with the index medication or switching to other biologic.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Mean Medication Possession Ratio (MPR) for Methotrexate	MPR was calculated as the total days supply of methotrexate between the first and including the last prescription/administration divided by the time between the first through and including last biologic prescription/administration days supply.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Proportion of Days Covered (PDC)	The PDC was calculated based on total days supply over the 12 months follow-up. The PDC was calculated by using the date of service and the day supply for each fill of the index medication.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Addition of Conventional Synthetic Disease-modifying Antirheumatic Drug (Cs-DMARDs) in Participants With Monotherapy	Participants with monotherapy who used additional csDMARD during post index period are reported.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Adherence to Cs-DMARDs in Participants With Combination Therapy	Adherence was calculated as the total day supply for csDMARDs divided by the number of days from the first claim during the follow-up until the end of the follow-up.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Number of Participants Who Met Different Medication Effectiveness Criteria	Adherence criteria: PDC >=0.8, proportion of days of supply during post-index period of 12 months.Dose escalation criteria: no increase in dose for index drug compared to starting dose during post-index period. Switch criteria: no switching from index drug to (different) biologic agent during post-index period. DMARD criteria: no addition of new csDMARD to index drug during post-index period. Oral glucocorticoid criteria: Participants with no claims for oral glucocorticoids in 6 months pre-index cannot receive oral glucocorticoids for greater than (>)30 days between (index date +91 days) to (index date + 365 days); or participants with claims for oral glucocorticoids in 6 months pre-index no increase in oral glucocorticoid dose during months 6-12 post-index.Injectable glucocorticoid criteria: at most 1 parenteral or intra-articular glucocorticoid joint injection on unique days after participant had been on bDMARD treatment for >3 months between (index date + 91) to (index date + 365).	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	All Cause Inpatient Visits Costs, Outpatient Visits Costs and Emergency Room (ER) Visits Costs During 12 Months Post Index Period	All cause inpatient visits costs, outpatient visits costs and emergency room visits costs during 12 months post index period are reported. Inpatient visit costs consisted of expenses during hospital visit for formal admission. Outpatient visit costs consisted of expenses when participants visited hospital but not for formal admission. Emergency room visit costs consisted of expenses during visit to hospital emergency room.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Rheumatoid Arthritis (RA) Related Inpatient Visits Costs, Outpatient Visits Costs and Emergency Room (ER) Visits Costs During 12 Months Post Index Period	RA related inpatient visit costs consisted of expenses during hospital visits for formal admission for RA. Outpatient visit costs consisted of expenses when participants visited hospital but not for formal admission for RA. ER visit costs consisted of expenses during visit to ER of hospital for RA.	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	All Cause Total Health Care Costs, Medical Costs, Pharmacy Costs During 12 Months Post-Index Period	All cause total health care costs, medical costs, pharmacy costs during 12 months post-index period are reported. All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	RA Related Total Health Care Costs, Medical Costs, Pharmacy Costs During 12 Months Post-Index Period	RA related total health care costs, medical costs, pharmacy costs during 12 months post-index period are reported. RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).	During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total All Cause Monthly Health Care Cost at Month 1 Post Index Date	All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure total all cause health care cost in dollars is reported for Month 1 post-index date.	Month 1 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total All Cause Monthly Health Care Cost at Month 2 Post Index Date	All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure total all cause health care cost in dollars is reported for Month 2 post-index date.	Month 2 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total All Cause Monthly Health Care Cost at Month 3 Post Index Date	All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure total all cause health care cost in dollars is reported for Month 3 post-index date.	Month 3 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total All Cause Monthly Health Care Cost at Month 4 Post Index Date	All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure total all cause health care cost in dollars is reported for Month 4 of post-index date.	Month 4 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total All Cause Monthly Health Care Cost at Month 5 Post Index Date	All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure total all cause health care cost in dollars is reported for Month 5 post-index date.	Month 5 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total All Cause Monthly Health Care Cost at Month 6 Post Index Date	All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure total all cause health care cost in dollars is reported for Month 6 post-index date.	Month 6 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total All Cause Monthly Health Care Cost at Month 7 Post Index Date	All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure total all cause health care cost in dollars is reported for Month 7 post-index date.	Month 7 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total All Cause Monthly Health Care Cost at Month 8 Post Index Date	All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure total all cause health care cost in dollars is reported for Month 8 post-index date.	Month 8 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total All Cause Monthly Health Care Cost at Month 9 Post Index Date	All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure total all cause health care cost in dollars is reported for Month 9 post-index date.	Month 9 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total All Cause Monthly Health Care Cost at Month 10 Post Index Date	All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure total all cause health care cost in dollars is reported for Month 10 post-index date.	Month 10 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total All Cause Monthly Health Care Cost at Month 11 Post-index Date	All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure total all cause health care cost in dollars is reported for Month 11 post-index date.	Month 11 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total All Cause Monthly Health Care Cost at Month 12 Post Index Date	All cause refers to cost spent due to all comorbidities including RA. Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure total all cause health care cost in dollars is reported for Month 12 post-index date.	Month 12 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total RA Related Monthly Health Care Cost at Month 1 Post Index Date	RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure RA related total all cause health care cost in dollars is reported for Month 1 post-index date.	Month 1 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total RA Related Monthly Health Care Cost at Month 2 Post Index Date	RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measurec RA related total all cause health care cost in dollars is reported for Month 2 post-index date.	Month 2 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total RA Related Monthly Health Care Cost at Month 3 Post Index Date	RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure RA related total all cause health care cost in dollars is reported for Month 3 post-index date.	Month 3 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total RA Related Monthly Health Care Cost at Month 4 Post Index Date	RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure RA related total all cause health care cost in dollars is reported for Month 4 post-index date.	Month 4 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total RA Related Monthly Health Care Cost at Month 5 Post Index Date	RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure RA related total all cause health care cost in dollars is reported for Month 5 post-index date.	Month 5 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total RA Related Monthly Health Care Cost at Month 6 Post Index Date	RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure RA related total all cause health care cost in dollars is reported for Month 6 post-index date.	Month 6 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total RA Related Monthly Health Care Cost at Month 7 Post Index Date	RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure RA related total all cause health care cost in dollars is reported for Month 7 post-index date.	Month 7 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total RA Related Monthly Health Care Cost at Month 8 Post Index Date	RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure RA related total all cause health care cost in dollars is reported for Month 8 post-index date.	Month 8 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total RA Related Monthly Health Care Cost at Month 9 Post Index Date	RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure RA related total all cause health care cost in dollars is reported for Month 9 post-index date.	Month 9 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total RA Related Monthly Health Care Cost at Month 10 Post Index Date	RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure RA related total all cause health care cost in dollars is reported for Month 10 post-index date.	Month 10 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total RA Related Monthly Health Care Cost at Month 11 Post-index Date	RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure RA related total all cause health care cost in dollars is reported for Month 11 post-index date.	Month 11 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Primary	Total RA Related Monthly Health Care Cost at Month 12 Post Index Date	RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). In this outcome measure RA related total all cause health care cost in dollars is reported for Month 12 post-index date.	Month 12 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)

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