Fig. 2.

GOLDEN 7 study schematic. Washout of more than 7 days required approval by the Sponsor. All doses were administered at the same time of day (± 1 h), 7 days apart. ^aSubjects had follow-up telephone contact on Day 36 (± 1 day) to assess safety. Subjects who discontinued prior to Visit 6 had follow-up telephone contact 5 to 7 days after their last study treatment. EOT, end of treatment