- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04599894
Reducing Postoperative Side Effect of Pregabalin
Effect of Application of Low Dose of Pregabalin in TJA Before the Day of Surgery on Reducing Postoperative Side Effect of This Medicine
Study Overview
Status
Intervention / Treatment
Detailed Description
Study design This prospective randomized controlled clinical trial was conducted at our institution in accordance with the Declaration of Helsinki. The Institutional Review Board approved the study (IRB number IRB00008484). We registered the clinical trial on The ClinicalTrials.gov Protocol Registration (NCT04599894) before the enrolment of the first participant. Written informed consent was obtained from each patient.
Participant recruitment Patients were eligible for inclusion if they were between 18 and 80 years of age and scheduled for a primary TJA. Exclusion criteria included: medical history of neuropathic pain or other non-arthritic chronic pain; Non-steroidal anti-inflammatory drug intolerance or long-term use of opioids; psychiatric disorders; motion sickness.
Sample size estimation The sample size was based on a preliminary study (under the same synergy of medications, celecoxib (Pfizer) 400mg and pregabalin (Pfizer) 75mg two hours pre-operatively orally, on the day of surgery). The preliminary study demonstrated that only one patient fell dizziness postoperatively in ten consecutive TJA patients who received 37.5mg pregabalin twice on the day before surgery, while four patient fell dizziness postoperatively in ten consecutive TJA patients receiving none on the day before surgery. Therefore the sample size was calculated by comparing estimated proportion using the Chi-squared statistic, a sample size of 58 (29 per group) would reveal differences at the 5% level of significance, and with a power of 0.8.
Randomization A computer-generated randomization schedule was used to assign patients to one of two treatment groups. The schedule was created by the clinical research center of our hospital, which was not involved in the clinical care of patients or in the conduct of the present trial.
Treatment protocol All patients scheduled to undergo primary TJA between November 2020 and April 2021 were screened for recruitment. Participants were recruited at their preoperative assessment visit two days before surgery and were randomly assigned to one of two treatment groups. Group 1 (G1) received pregabalin 37.5 mg twice orally (PO) on the day before surgery (at 8 am and 6 pm, respectively), and celecoxib 400mg as well as pregabalin 75mg PO at two hours pre-operatively; Group 2 (G2) received none on the day before surgery and the same dose of celecoxib and pregabalin PO at two hours pre-operatively. Crystalloid for resuscitation was started on the morning of surgery. Perioperative antibiotics, cefazolin sodium, 2g, and tranexamic acid 1g were administered within one hour of skin incision via intravenous (IV) drip. Dolasetron 12.5mg IV and dexamethasone 5mg IV were administrated during the induction of anesthesia. Patients were sedated with midazolam and received a general anesthesia combined with fascia iliaca compartment block (FICB) for THA(0.2% ropivacaine 60mg for each joint) and adductor canal as well as infiltration between the popliteal Artery and Capsule of the Knee (iPACK) block for TKA (totally 0.2% ropivacaine 60mg for each joint). All procedures were performed by one group of surgeons (QX, GYH, ZXY, ZJT) through a posterolateral approach for THA and medial parapatellar approach for TKA. Periarticular injection (0.2% ropivacaine 80mg, compound betamethasone 7mg, ketorolac 30mg, epinephrine 0.3mg for each joint) was performed before implanting prosthesis. Cementless prosthesis (Depuy, Corail® Total Hip System) was used in all hips, and cemented prosthesis (Depuy, Attune® Total Knee System) was used in all knees. Neither drain was used in all wounds, nor was urinary catheter. IV patient-controlled analgesia (PCA) was not administered in these participants. Since two hours after extubation under general anesthesia, participants were allowed to drink water and progressively transit to their daily diaries. They were instructed to make independent postoperative transfers at six hours after extubation, which was taken as the final time point to determine the success of EARS pathway. Then these patients were transferred to a rehabilitation unit in the same hospital, cryotherapy and rehabilitation protocols were ordered until discharge. Rivaroxaban (10mg at 8 am per day, Bayer), celecoxib (200mg twice a day, at 8 am and 2 pm, respectively) as well as pregabalin (75mg per day at 6 pm) until the third postoperative day. Patients were instructed to maintain a VAS (visual analogous scale) pain score of between 1 and 3. If the VAS pain score was ≥4 at rest, oxycodone-acetaminophen (5mg/325mg, per dose, Mallinckrodt Inc.) would be used every six hours as needed for postoperative rescue analgesia. The discharge criteria included: patients' general well-being and acceptable pain control (VAS<4); dry wound; ability to safely mobilize with crutches and climb the stairs; patients' express acceptance of discharge; patients and family members learned the home-based exercise protocols for the first six weeks. Rivaroxaban was continued to use for five weeks. Cryotherapy, rehabilitation protocols and celecoxib 200mg twice a day were continued to use for six weeks postoperatively.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Changchun, China
- The First Hospital of Jilin University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- clinical diagnosis of knee osteoarthritis;
- avascular necrosis of femoral head;
- dysplasia of the hip joint.
Exclusion Criteria:
- medical history of neuropathic pain or other non-arthritic chronic pain;
- Non-steroidal anti-inflammatory drug intolerance or long-term use of opioids;
- psychiatric disorders;
- motion sickness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
SHAM_COMPARATOR: control group
Oral administration of Pregabalin (75mg) 2h before operation; and oral administration of Pregabalin (75mg) at 18 pm from the first day after operation to discharge.
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75mg pregabalin postoperatively
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EXPERIMENTAL: study group
Oral administration of Pregabalin (37.5mg) at 8 am and 18 pm 1 d before operation; oral administration of Pregabalin (75mg) 2h before operation; and oral administration of Pregabalin (75mg) at 18 pm from the first day after operation to discharge.
|
37.5mg pregabalin preoperatively + 75mg pregabalin postoperatively
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dizziness
Time Frame: at the night pre-operatively (at 8 pm)
|
assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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at the night pre-operatively (at 8 pm)
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dizziness
Time Frame: at two hours pre-operatively
|
assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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at two hours pre-operatively
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dizziness
Time Frame: at two hours post-operatively
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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at two hours post-operatively
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dizziness
Time Frame: at four hours post-operatively
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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at four hours post-operatively
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dizziness
Time Frame: at six hours post-operatively
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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at six hours post-operatively
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dizziness
Time Frame: on the morning of postoperative day (POD) 1 (at 8 am)
|
assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
|
on the morning of postoperative day (POD) 1 (at 8 am)
|
dizziness
Time Frame: on the morning of postoperative day (POD) 2 (at 8 am)
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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on the morning of postoperative day (POD) 2 (at 8 am)
|
dizziness
Time Frame: on the morning of postoperative day (POD) 3 (at 8 am)
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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on the morning of postoperative day (POD) 3 (at 8 am)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
nausea
Time Frame: at the night pre-operatively (at 8 pm)
|
assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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at the night pre-operatively (at 8 pm)
|
nausea
Time Frame: at two hours pre-operatively
|
assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
|
at two hours pre-operatively
|
nausea
Time Frame: at two hours post-operatively
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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at two hours post-operatively
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nausea
Time Frame: at four hours post-operatively
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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at four hours post-operatively
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nausea
Time Frame: at six hours post-operatively
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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at six hours post-operatively
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nausea
Time Frame: on the morning of postoperative day (POD) 1 (at 8 am)
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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on the morning of postoperative day (POD) 1 (at 8 am)
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nausea
Time Frame: on the morning of postoperative day (POD) 2 (at 8 am)
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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on the morning of postoperative day (POD) 2 (at 8 am)
|
nausea
Time Frame: on the morning of postoperative day (POD) 3 (at 8 am)
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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on the morning of postoperative day (POD) 3 (at 8 am)
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vomiting
Time Frame: at the night pre-operatively (at 8 pm)
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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at the night pre-operatively (at 8 pm)
|
vomiting
Time Frame: at two hours pre-operatively
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
|
at two hours pre-operatively
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vomiting
Time Frame: at two hours post-operatively
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
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at two hours post-operatively
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vomiting
Time Frame: at four hours post-operatively
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
|
at four hours post-operatively
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vomiting
Time Frame: at six hours post-operatively
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
|
at six hours post-operatively
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vomiting
Time Frame: on the morning of postoperative day (POD) 1 (at 8 am)
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assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
|
on the morning of postoperative day (POD) 1 (at 8 am)
|
vomiting
Time Frame: on the morning of postoperative day (POD) 2 (at 8 am)
|
assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
|
on the morning of postoperative day (POD) 2 (at 8 am)
|
vomiting
Time Frame: on the morning of postoperative day (POD) 3 (at 8 am)
|
assessed on a 4-point verbal rating scale (VRS) (none, mild, moderate and severe)
|
on the morning of postoperative day (POD) 3 (at 8 am)
|
sedation
Time Frame: at the night pre-operatively (at 8 pm)
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ssessed by The Richmond Agitation-Sedation Scale (RASS)
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at the night pre-operatively (at 8 pm)
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sedation
Time Frame: at two hours pre-operatively
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ssessed by The Richmond Agitation-Sedation Scale (RASS)
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at two hours pre-operatively
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sedation
Time Frame: at two hours post-operatively
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ssessed by The Richmond Agitation-Sedation Scale (RASS)
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at two hours post-operatively
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sedation
Time Frame: at four hours post-operatively
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ssessed by The Richmond Agitation-Sedation Scale (RASS)
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at four hours post-operatively
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sedation
Time Frame: at six hours post-operatively
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ssessed by The Richmond Agitation-Sedation Scale (RASS)
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at six hours post-operatively
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sedation
Time Frame: on the morning of postoperative day (POD) 1 (at 8 am)
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ssessed by The Richmond Agitation-Sedation Scale (RASS)
|
on the morning of postoperative day (POD) 1 (at 8 am)
|
sedation
Time Frame: on the morning of postoperative day (POD) 2 (at 8 am)
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ssessed by The Richmond Agitation-Sedation Scale (RASS)
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on the morning of postoperative day (POD) 2 (at 8 am)
|
sedation
Time Frame: on the morning of postoperative day (POD) 3 (at 8 am)
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ssessed by The Richmond Agitation-Sedation Scale (RASS)
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on the morning of postoperative day (POD) 3 (at 8 am)
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opioids consumption
Time Frame: from surgery day to discharge day
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calculated as a product of the morphine equivalence and count, and intraoperative or any postoperative opioids consumption were recorded
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from surgery day to discharge day
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independent transfers at six hours post-op
Time Frame: at six hours post-operatively
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calculated as a product of the morphine equivalence and count, and They were instructed to make safely independent postoperative transfers at six hours after extubation.
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at six hours post-operatively
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pain score
Time Frame: at six hours post-operatively
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Pain scores at rest and mobilization were assessed using VAS (0=no pain; 10=worst pain)
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at six hours post-operatively
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pain score
Time Frame: on the morning of postoperative day (POD) 1 (at 8 am)
|
Pain scores at rest and mobilization were assessed using VAS (0=no pain; 10=worst pain)
|
on the morning of postoperative day (POD) 1 (at 8 am)
|
pain score
Time Frame: on the morning of postoperative day (POD) 2 (at 8 am)
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Pain scores at rest and mobilization were assessed using VAS (0=no pain; 10=worst pain)
|
on the morning of postoperative day (POD) 2 (at 8 am)
|
pain score
Time Frame: on the morning of postoperative day (POD) 3 (at 8 am)
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Pain scores at rest and mobilization were assessed using VAS (0=no pain; 10=worst pain)
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on the morning of postoperative day (POD) 3 (at 8 am)
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time to readiness for discharge
Time Frame: from the day of independent transfers to the day of meeting discharge criteria
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Time to readiness for dischargey was calculated by day.
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from the day of independent transfers to the day of meeting discharge criteria
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time to readiness for independent transfers
Time Frame: from the hour of extubation to the hour of independent transfers
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Time to readiness for dischargey was calculated by hour.
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from the hour of extubation to the hour of independent transfers
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- QiXin1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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