Schedule of participant enrolment, interventions and assessments
| Timepoint | Trial period | ||||||||
| Pre-enrolment | Enrolment | Post-allocation* | |||||||
| Antenatal | Postnatal 0–8 weeks | 1 month | 3 months | 6 months | 9 months | 1 year | 3 years | 6 years | |
| Pre-enrolment | |||||||||
| Registration of interest | X | ||||||||
| Enrolment | |||||||||
| Eligibility screen | X | ||||||||
| Informed consent | X | ||||||||
| Randomisation | X | ||||||||
| Interventions | |||||||||
| Paracetamol only (as needed) | X | X | X | X | X | ||||
| Ibuprofen only (as needed) | X | X | X | X | X | ||||
| Provision of trial supplies | |||||||||
| Wallet cards, trial diary, sticker, fridge magnet, soft toy | X | ||||||||
| Trial medication supply (as needed) | X | X | X | X | X | ||||
| Assessments | |||||||||
| Maternal enrolment questionnaire | X | ||||||||
| 1-month questionnaire | X | ||||||||
| 3-month questionnaire | X | ||||||||
| 6-month questionnaire | X | ||||||||
| 9-month questionnaire | X | ||||||||
| 1-year questionnaire | X | ||||||||
| 3-year questionnaire | X | ||||||||
| 6-year questionnaire | X | ||||||||
*For infants born <37 weeks’ gestation, follow-up is based on chronological age.