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Table 2 Study schedule and procedures

From: Effect of a newly developed pastille on the salivary flow rate in subjects with dry mouth symptoms: a randomized, controlled, monocentric clinical study

 

Screening Day − 7 to − 1

Day 1

Day 3

Informed consent

X

  

Demographical data, medical history and pregnancy test

X

  

Medical history of dry mouth

X

  

Physical examination of the oral cavity

X

 

X

Vital signs (blood pressure and pulse rate)

X

 

X

Concomitant diseases and medication/treatment

X

  

Inclusion and exclusion criteria

X

X

 

VAS assessment of dry mouth

X

X1)

X1)

Saliva sampling for salivary flow measurement

 

X

X

(1) Unstimulated (baseline measurements)

(2) Rest period (at least 5 min)

(3) Stimulated

Salivary surface tension measurement

 

X

X

Raman spectroscopy (subgroup, n = 6)

 

X

 

Tolerability assessment (locally by an investigator and subjective by the subject)

 

X

X

Adverse events and change in concomitant medication

 

X

X

  1. Before and after sucking