Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-centre, Double-blind, Randomised, Two-stage, Parallel-group Study to Assess the Efficacy and Safety of the Fixed Dose Combination of Ibuprofen 400 mg and Caffeine 100 mg Versus Ibuprofen 400 mg, Caffeine 100 mg and Placebo in Patients With Postoperative Dental Pain
Brief Summary: The primary objective of this study is to compare the efficacy of a combination product containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as placebo for the treatment of post-surgical dental pain over an eight-hour period followed by a single dose of study medication (study stage 1). A secondary objective is to evaluate efficacy of multiple doses of the combination in comparison to ibuprofen alone over a 5-day post-surgical period (study stage 2).


Options:
A: Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h) (0 to 8 hours)
B: Composite Pain 1 (End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)); Composite Pain 2 (End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)); Composite Pain 3 (End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)); Composite Pain All (End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)); Overall Satisfaction (At time of post-operative visit (day 9 +/- 5 days)); Pain Worst 1 (End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)); Pain Worst 2 (End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery); Pain Worst 3 (End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)); Pain Worst All (End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)); Pain Average 1 (End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)); Pain Average 2 (End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)); Pain Average 3 (End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)); Pain Average All (End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery))
C: Pain Severity (Average pain score will be collected for preoperative visit (the day before surgery)); Pain Severity (Average pain score was collected for postoperative day 1); Pain Severity (Average pain score will be collected for postoperative day 2); Pain Severity (Average pain score will be collected for postoperative day 3); Pain Severity (Average pain score will be collected for postoperative day 4); Pain Severity (Average pain score will be collected for postoperative day 5); Pain Severity (Average pain score will be collected for postoperative day 6); Pain Severity (Average pain score will be collected for postoperative day 7); Medication Log (Postoperative day 1 to 7)
D: Safety (1.5 years)

Answer: A