 The lower age limit for the clinical trial was initially set to 3 years of age in the protocol. The trial planned for the inclusion of participants in three age categories. Age 3 to less than 6 years young children, age 6 to less than 12 years older children and age 12 to less than 18 years of age adolescents. There was a request by the Paediatric Committee PDCO at the European Medicines Agency to include participants 2 years of age very young children. The protocol amendment thus planned to combine the two youngest age groups into a single reporting group. The protocol amendment only planned that the very young children group would have separate analysis for the Faces Pain Scale Revised FPS-R Scale and for the presentation of the serum concentrations, because the pharmacokinetic sampling scheme used in the 2 year old participants was different from the young children group aged 3 to less than 6 years. 