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As part of their agreements with CMS, the manufacturers must demonstrate how these lifestyle support programs will meet the program requirements, including encouraging healthy eating and increasing physical activity, supporting medication adherence, ensuring engagement with the program on a regular basis, and ensuring availability of this program to all patients receiving these medications, either online or offline for those who have limited digital access

& Browne, M

Additional documentation includes reconstitution instructions, storage temperature specifications, and expiration timelines for both lyophilised and reconstituted forms

At the 12-week mark, a PASI 75 response was reached in 40.0% of the patients receiving Dunaliella and about 27% of the control patients, though this did not reach the level of significance (Greenberger 2012)