Fig. 1: REMARK diagram for patient enrollment, exclusions, and disposition.

QNS quantity not sufficient, M1 month 1, M2 month 2, M3 month 3, M12 month 12, EOS end of study.

QNS quantity not sufficient, M1 month 1, M2 month 2, M3 month 3, M12 month 12, EOS end of study.