Table 1

Study definitions

Area	A subdistrict within Lilongwe, Malawi.
Non-severe fast breathing pneumonia	Cough <14 days or difficulty breathing and fast breathing for age.
Fast breathing for age	Respiratory rate >50 breaths per minute (for children 2 to <12 months of age) or >40 breaths per minute (for children >12 months of age).
Treatment failure criteria
Any time on or before day 4	Severe respiratory distress (grunting, nasal flaring, head nodding and/or chest indrawing). Hypoxaemia (arterial oxyhaemoglobin saturation <90% in room air, as assessed non-invasively by a pulse oximeter). General danger sign (lethargy or unconsciousness, convulsions, vomiting everything, inability to drink or breast feed, stridor while calm). Missing ≥2 study drug doses due to vomiting. Change in antibiotics prescribed by a study clinician. Hospitalisation due to pneumonia (if not initially admitted). Prolonged hospitalisation or readmission due to pneumonia (if initially admitted). Death.
On day 4 only	Axillary temperature ≥38°C in the absence of a diagnosed coinfection with fever symptoms (eg, malaria).
Clinical relapse criteria
Any time after day 4	Recurrence of signs of pneumonia. Signs of severe disease.