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Kai Kwok, is a Senior Pharmaceutical Quality Assessor (SPQA) in the Division of Product Quality Assessment I, Office of Product Quality Assessment I, Office of Pharmaceutical Quality, CDER at FDA

Technical contraindications and patient factors may limit applicability, requiring individualised assessment [68]

Here's what the FITTER consensus and EMA labels actually say

Clear instructions are included, and patients can reach out to support staff with any questions

Researchers suggest this is due to treatment adherence, dose adjustments, and lifestyle variations, which are more difficult to control in a clinical setting

Until then, this is a calculated bet not a bluff