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While we appreciate the applicant's explanation about the propensity score matching in Geldmaker et al

The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Synthesize type I collagen matrix (osteoid) then mineralize it with calcium phosphate creating hardened bone

Liver function tests (LFTs) should be performed to assess disease activity and guide overall management

(2023) collected patient-reported adverse event data as a secondary endpoint, the study would have been severely underpowered to detect any group differences in adverse events