Efficacy and safety, primary and secondary endpoints.

*On days of antibiotic therapy patients showing an exanthema or vomiting or diarrhea as stated in the patient’s diary from day 1 up to day 14.†Occurrence of any of the following entities: complications from pneumonia or other LRTI (e.g., parapneumonic effusions in need of puncture, empyema, lung abscess, necrotizing pneumonitis, acute respiratory distress syndrome) or occurrence of SAEs (hospital readmission, admission to intensive care unit, unexpected life threatening condition, condition of compromising sequelae or death occurring in the 14 days following the inclusion of the patient) or disease specific failure, including hospital readmission, recurrent infection in need of antibiotics or development of any co-morbid condition in need of antibiotics irrespective of the primary LRTI diagnosis, worsening of ≥20% of daily restrictions from LRTI according to parent interview and diary, new onset of respiratory distress or worsening of pre-existing respiratory distress (i.e., tachypnea, and or dyspnea in spite of β2-mimetic treatment) or increasing or new onset of O2 requirement or development of global respiratory insufficiency – increasing pCO2. * number of individuals with available data for a given endpoint.