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. 2023 Mar 31;102(13):e33367. doi: 10.1097/MD.0000000000033367

Table 1.

Schedule of BePaiR study activities.

At investigational site DAY 0 At home from D 0 to D 6 At investigational site D 7 (+2)
Visit V0 screening/baseline V1 efficacy evaluation V2/ETTV final visit
Time 0 1 min 2 min 5 min 10 min 15 min 30 min 60 min 120 min
Informed consent and personal data processing X
Demographic data and medical history X
Physical examination and vital signs X X
Previous treatments X
Concomitant treatments X X X
Pregnancy test X
Rapid strep test X
Inclusion/Exclusion criteria X
URTI questionnaire X
TPA X X
STPIS X X X
DSS X X X X X X X
SwoTS X X X X X X X
QuaSTI X X X
Randomization X
Drug administration X X
Adverse events X X X X X X X X X X X
STRRS X X X X X X X X X
Drug delivery X
Patient card delivery X
Patient diary delivery X
Patient diary collection and IMP return X
PSQ X

DSS = difficulty swallowing scale, IMP = investigational medicinal product, PSQ = patient satisfaction questionnaire, QuaSTI = qualities of sore throat index, STPIS = sore throat pain intensity scale, STRRS = sore throat relief rating scale, SwoTS = swollen throat scale, TPA = Tonsillo-Pharyngitis assessment, URTI = upper respiratory tract infection.