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Table 5 Detailed timetable of procedures and assessments in periods 1, 2, 3, and 4

From: IMI2-PainCare-BioPain-RCT1: study protocol for a randomized, double-blind, placebo-controlled, crossover, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by peripheral nerve excitability testing (NET)

Clock time Time relative to dose (minutes) Time relative to HFS (minutes) Dose HFS PK PD Hyperalgesia testing** PROMs (D)rink
(M)eal
08:00 − 150 − 60        
08:30 − 120 − 30       X  
09:00 − 90 0   X      
09:30 − 60 30     [1]    
10:00 − 30 60        
10:30 0 90 X       D
11:00 30 120        
11:15 45 135    [1]     
11:30 60 150     [2]    
12:00 90 180        
12:30 120 210      X   D
13:00 150 240    [2]     
13:30 180 270     [3]    
14:00 210 300        
14:30 240 330    [3]     M
15:00 270 360        
15:30 300 390       X  
16:00 330 420        
16:30 360 450     [4]    
17:00 390 480        
17:30 420 510    [4]     D
18:00 450 540        
Next day    (5)*     
  1. *The PK sample on next day can be taken at any suitable time provided that the exact time of sampling is precisely recorded. **Hyperalgesia testing at the sensitized and contralateral forearm, harmonized across all four IMI2-PainCare-BioPain RCTs. Reproduced from [2]