Please select the eligibility criteria that correspond to the clinical trial below.
Title: Double Blinded, Randomized, Active Drug Comparative, Multi-center, Phase IV Clinical Study to Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients
Brief Summary: This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and Joins tablet in the treatment of osteoarthritis of the knee.


Options:
A: Inclusion Criteria:

* Symptoms of osteoarthritis of the hip or knee for a minimum of six months
* History of hip or knee pain due to osteoarthritis requiring the use of NSAIDs, acetaminophen or another analgesic agent on a regular basis (\>= three days/week) for at least three months before the screening visit
* History of positive benefit with acetaminophen use for osteoarthritis pain
* History (ie, at any time in the past since diagnosis) of osteoarthritis pain of the hip or knee when not taking osteoarthritis analgesic medication
* Subjects must report a history of a pain level of moderate, moderately severe, or severe, a WOMAC pain score \>= 65 at baseline, and a 20% or greater increase in their pain score relative to their score at screening

Exclusion Criteria:

* History of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit
* Grade 1 or grade 4 severity of the study joint based on the Kellgren and Lawrence radiographic criteria
* Signs of clinically important active inflammation of the study knee joint including redness, warmth, and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits
* Secondary osteoarthritis of the study joint including, but not limited to, septic arthritis, inflammatory joint disease, gout, Paget's disease of bone, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemochromatosis, Wilson's disease, avascular necrosis, or primary osteochondromatosis
* History of acute inflammatory arthritis or pseudogout of the study joint.
B: Inclusion Criteria:

* Patients ≥40 and ≤ 80years of age
* Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren \& Lawrene radiographic entry criteria
* Stable osteoarthritis during 3 months
* Score of 100mm pain VAS ≤ 80mm at screening
* Score of 100mm pain VAS ≥ 50mm at baseline
* Written consent form voluntarily

Exclusion Criteria:

* Disease of spine or other Lower limb joints that could affect to evaluate the efficacy
* History of surgery or arthroscopy of the study joint within 6 months
* Trauma of study joint within 12 months
* Medication of constantly(more than 1 week) corticosteroid by oral within 3 months
* Medication of intra-articular injection within 3 months
* Diagnosed with psychical disorder, and taking medication
* History of upper gastrointestinal ulceration within 6 months
* History of upper gastrointestinal bleeding within 12 months
* Serum creatinine, ALT, AST, total bilirubin over UNL X 2.0 at screening test
* History of hypersensitivity to LAYLA, JOINS, or NSAIDs
* Participation in another clinical trials within 4 weeks
* Medication of constantly (more than 1 week) narcotic analgesics within 3 months
* Not consent about using effectual contraception method during trial
* Pregnant or lactating woman
* Investigator's judgment
C: Inclusion Criteria:

* Knee-OA detected by x-ray (Kellgren \& Lawrence grade 1 or greater)
* KOOS4 of ≤ 75
* Considered not to be a candidate for Total Knee Replacement (TKR) by the orthopedic surgeon.
* The participant is \> 18 years of age.
* The participant can provide relevant and adequate, informed consent.

Exclusion Criteria:

* Prior TKA ipsilateral
* Rheumatoid arthritis
* Mean VAS \> 60mm the last week on a 0-100mm scale
* Possible pregnancy or planning pregnancy;
* Inability to comply with the protocol;
* Inadequacy in written and spoken Danish.
D: Inclusion Criteria:

* Participants who are scheduled to have standard primary (non-revision) unilateral (having to do with only 1 side of a structure) total knee replacement arthroplasty (TKRA-surgery to fix a joint) for non-inflammatory (no swelling, redness, and pain in tissues caused by injury or damage) degenerative joint disease (NIDJD)
* Participants who are capable of oral (having to do with the mouth) intake
* Women must be: postmenopausal (for at least 1 year), surgically sterile, abstinent (not having sexual intercourse), or practicing a highly effective method of birth control before participation in the study and who agree to continue to use the same method of birth control throughout the study in cases of women of childbearing potential
* Male participants must practice contraception, and must agree not to donate his sperms for 1 month after the last dose of study drug
* Participants who will complain of baseline pain of intensity of greater than or equal to 4 on 11-point numeric rating scale (NRS) measured within 1 hour prior to randomization (study drug assigned by chance) and a maximum of 6 hours after discontinuation of participant controlled analgesia (PCA) after at least 12 hours of application following TKRA

Exclusion Criteria:

* Participants with Illness history (severe \[very serious, life threatening\] hepatic \[having to do with the liver\] failure, severe renal \[having to do with the kidney\] failure; severe respiratory depression; risk for mental fog with head injury or brain lesions \[abnormal area of tissue, such as a wound, sore, rash, or boil\]; digestive ulcer \[sore\], severe blood abnormalities; severe cardiac insufficiency; aspirin asthma \[asthmatic attack-breathing disorder in which there is a wheezing and difficulty in breathing; caused by non-steroidal anti-inflammatory drugs\] or history of aspirin asthma; history of epilepsy \[seizure disorder\]; rheumatism, significant psychiatric disorder or taking antipsychotic drugs for psychiatric treatment)
* Administration of disallowed therapy such as: administration of oral, patch, injection or local analgesics (drug used to control pain) acting centrally (the brain and the spinal cord) or peripherally (not central) before study drug administration after completion of PCA application, surgery is conducted simultaneously in addition to TKRA, administration of monoamine oxidase (MAO) inhibitors or discontinuation of the administration within 2 weeks, tricyclic antidepressants that may increase the seizure (sudden, uncontrolled muscle spasms and loss of consciousness resulting from abnormal brain function) risk when concomitantly (given at the same time) administered, neuroleptics, or drugs that may lower the seizure threshold, use of sedatives (a medication to calm or make less anxious) other than that used for general anesthesia (loss of sensation or feeling) during surgery
* Participants who used any study drug or investigational medical device within 30 days before the start of the treatment
* Participants requiring postoperative intensive care unit (ICU) care
* Participants having hypersensitivity to tramadol or acetaminophen

Answer: B