3.1. Subjects
HYDROXYAPATITE
Overall, 194 subjects were included: 97 (50%) applied the hydroxyapatite toothpaste (test toothpaste) and 97 (50%) applied the fluoride toothpaste (control toothpaste) as randomized. The study was prematurely terminated in 20 (10.3%) subjects for several reasons (test toothpaste: All subjects who performed at least one follow-up visit (V2, V3, or V4) were included in the intention-to-treat (ITT) population. The study was terminated in five subjects at visit V1 (baseline); i.e., these subjects were not included in the ITT population. In total, 189 (97.4%) subjects were included in the ITT population. Finally, 174 (89.7%) subjects completed visit V4 (final visit): hydroxyapatite toothpaste: The primary endpoint was analyzed for the PP population and, in addition, repeated for sensitivity reasons for the ITT population.