Figure 1.

Flow chart.

^*3 patients who missed the study visits could be contacted by phone to assess clinical outcomes.

^aIncluding all patients because they were randomized and have available outcome data.

^bIncluding patients who received the intervention they were allocated to and have available outcome data.

^cIncluding patients who received the intervention they were allocated to, with an interval of 4 weeks (± 1 week) between first and second vaccination dose and provided outcome data at 12 weeks (± 1 week). Results only presented within appendix.

Abbreviations: ITT, intention to treat; pp, per-protocol; SAE, serious adverse event.