Analysis population | HC treatment group | Placebo treatment group |
---|---|---|
Intention to treat ‘as randomised’ | HC randomisation: • Including all protocol deviations (e.g., in eligibility criteria) | Placebo randomisation: • Including all protocol deviations (e.g., in eligibility criteria) |
As treated ‘actual treatment’ | Patient received HC (at least one dose), regardless of allocated treatment at randomisation: • Including those infants who received rescue open-label corticosteroids as described according to protocol • Including those infants who received rescue open-label corticosteroids not following protocol (protocol deviation) • Including those infants with other protocol deviations (e.g., in eligibility criteria) | Patient received placebo (at least one dose), regardless of allocated treatment at randomisation: • Including those infants not receiving any corticosteroid dose for pulmonary reasons • Excluding those infants who received rescue open-label corticosteroids following study protocol • Excluding those infants who received rescue open-label corticosteroids not following study protocol • Including those infants with other protocol deviations (e.g., in eligibility criteria) |
Per protocol | HC randomisation and treated according to study protocol: • Including those infants receiving rescue open-label corticosteroids as described by the study protocol • Excluding those infants receiving rescue open-label corticosteroids not according to study protocol (protocol deviation) • Excluding other protocol deviations (e.g., in eligibility criteria) | Placebo randomisation and treated according to study protocol: • Including those infants receiving rescue open-label corticosteroids following study protocol • Excluding those infants receiving rescue open-label corticosteroids not following study protocol (protocol deviation) • Excluding other protocol deviations (e.g., in eligibility criteria) |