Randomization, Follow-up, and Analysis Populations
The intention-to-treat (ITT) population included 543 patients who underwent randomization. The modified ITT population excluded 32 persons who were identified as being vaccinated before randomization. The per-protocol population included the patients in the modified ITT population except 160 persons who did not adhere to assigned recommendation. The completed telephone follow-up population included the patients in the ITT population, except 37 persons who did not complete 3-month telephone call follow-up. The month 3 in-person evaluable population included the patients in the ITT population except 294 persons who did not complete month 3 in-person follow-up.