Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Placebo- and Active-controlled Multi-country, Multi-centre Parallel Group Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of 400 mg Ibuprofen and 100 mg Caffeine Compared to Ibuprofen 400 mg and Placebo in Patients With Acute Lower Back or Neck Pain.
Brief Summary: To assess the efficacy and safety of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a 400 mg ibuprofen tablet for the treatment of acute lower back or neck pain. To assess the safety and tolerability of a 400 mg ibuprofen/100 mg caffeine tablet in comparison to a 400 mg ibuprofen tablet and a placebo tablet.


Options:
A: Inclusion Criteria:

* Acute LBP(with or without leg pain), with onset within past 4 weeks
* Severe disability as assessed by an Oswestry Disability Index of 60% or higher
* Age between 20 and 60
* Given consent to lumbar MRI
* Voluntary participation with written consent given to study consent form

Exclusion Criteria:

* Diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc.
* Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.
* Progressive neurologic deficit(s) or concurrent severe neurological symptoms
* Unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc.
* Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher
* Experience of gastroenteric complications after taking NSAIDs or currently undergoing treatment for digestive disorders
* During pregnancy or suspected pregnancy
* Subjects considered unsuitable for clinical trial by the researcher
B: Inclusion Criteria:

* LBP duration \<= 2 weeks
* No trauma to low back within previous month
* No radicular symptoms
* No history of low back pain or history of only infrequent episodes

Exclusion Criteria:

* Medication allergies or contra-indications
* Not available for follow-up
* Chronic pain syndrome
C: Inclusion criteria:

* Signed and dated written informed consent at Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation.
* Male or female patients who are \>=18 years with current diagnosis of acute back pain or of neck pain for at least 24 hours, but less than 21 days.
* Acute back pain or acute neck pain resulting in Pain on Movement (POM) \>=5 on the 0-10 Numerical Rating Scale (NRS) for at least one POM procedure out of 5 standardised procedures.
* Sensitivity to algometric pressure on the painful trigger point \<= 25 N/cm².
* Women of childbearing potential must be ready and able to use highly effective methods of birth control.
* Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaires.
* Examined by the attending physician and medically cleared to participate in the study
* In good general health, with a body mass index (BMI) \< 30, and have no contraindications to any of the study medication

Exclusion criteria:

* History of 3 or more episodes of back or neck pain in the last 6 months excluding the current episode.
* Patients with pain at rest \>= 9
* Patient with chronic back or neck pain as defined as pain for 3 weeks or longer.
* Back or neck pain that is attributable to any identifiable cause (eg. disc prolapse, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumour)
* Any strains of the back or neck muscles documented by clinical evaluation and anamnesis that occurred 21 days to 3 months prior to the screening visit.
* Surgery due to back or neck pain or rehabilitation due to back or neck pain in the last 12 months.
* Prior use within the last 3 days before Visit 1 or concomitant use of any anti- inflammatory drugs, heparinoids, muscle relaxants or analgesics (including but not limited to short-acting glucocorticoids, non-steroidal anti-inflammatory drugs \[NSAIDs\], herbal preparations) for the same indication or other indications.
* Spinal injections should have been discontinued in due time (investigator's judgment) before patient enrollment to allow complete wash-out of the active ingredient based on investigator's judgment.
* Known severe hepatocellular insufficiency, severe renal insufficiency or Gilbert's syndrome (Morbus Meulengracht)
* Patients taking Central Nervous System (CNS) or other psychotropic drugs, or any nutritional supplement known to have psychotropic effects such as St. John's Wort, Chapparal, Comfrey, Germander, Gin Bu Huan, Kava, Pennyroyal Skullcap, or Valerian within two months of taking the first dose of study medication. Patients who have been on stable doses of these medications for at least two months will be allowed into the study, as long as they maintain this dose throughout the study, and their condition is judged stable by the Principal Investigator
* Any other medical condition that would interfere with efficacy and safety assessments based on investigator's judgment or any on-going clinical condition that would jeopardize patient's or site personnel's safety or study compliance based on investigator judgment
* Further exclusion criteria apply
D: Inclusion Criteria:

* Non-radicular, non-traumatic low back pain of no more than 2 weeks duration

Exclusion Criteria:

* Back pain longer than 2 weeks
* Prior to the acute attack of low back pain, back pain once per month or more frequently
* Prior to the acute attack of low back pain, daily or near daily use of pain medication

Answer: C