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Because this study period took place during the COVID-19 global pandemic and in-person visits were limited, the ability to obtain outcome measurements such as HbA 1C concentration and weight values was affected, therefore limiting the sample size due to a lack of patients with available follow-up data

Amulic B, Cazalet C, Hayes GL, Metzler KD, Zychlinsky A

Lisco G, De Tullio A, Disoteo O, De Geronimo V, Piazzolla G, De Pergola G, Giagulli VA, Jirillo E, Guastamacchia E, Sabba C, et al

FDA identified particular concern for proposed injectable exposure because no clinical immunogenicity or aggregation studies were available