STATISTICAL ANALYSIS
comorbidity
SENSITIVITY, INFLUENZA
The statistical analysis planPre-planned supplementary analyses were done to provide additional insights: (i) including follow-up time after receipt of a COVID-19-specific vaccine; (ii) excluding episodes starting ≤14 days from randomisation; (iii) censoring participants at any subsequent vaccination (e.g., influenza vaccine); (iv) using the ITT population. Sensitivity analyses were also done: (i) restricted to episodes occurring after BCG/placebo; (ii) using PCR/RAT results only (without serology) for defining COVID-19 episodes (in the ITT population); (iii) using less conservative censoring rules for missing data. Pre-planned sub-group analyses were done by: (i) age group (<40 years/40 to 59 years/≥60 years); (ii) presence of comorbidities (yes/no, and by comorbidity); (iii) geographical location (Brazil/Europe); (iv) sex (male/female); (v) history of previous BCG (BCG-naïve/previous BCG) for the primary analysis.