| Lansoprazole vs placebo | 81 infants | 81 infants | |
| Orenstein et al 14 | |||
| Primary efficacy: responder rate, n (%) | 44 (54%) | 44 (54%) | NS |
| AEs, n (%) | 50 (62%) | 37 (46%) | NS |
| SAEs, n (%) | 10 (12%) | 2 (2%) | 0. 032 |
*P values as provided in the original publication.
AEs, adverse events; GOR, gastro-oesophageal reflux; GORD, gastro-oesophageal reflux disease; NS, not significant; SAEs, serious adverse events.