Theoretical scenario: A phase III clinical trial was performed in an attempt to cure type I diabetes mellitus (T1DM). A

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Theoretical scenario: A phase III clinical trial was performed
in an attempt to cure type I diabetes mellitus (T1DM). A randomized
clinical control trial was conducted, in which 500 adult patients
living with T1DM (male and female, 18-100 years of age) were
administered either a placebo or a novel drug treatment
(administered monthly). Subjects were then monitored every three
months for a period of five years, including blood analysis for the
presence of blood insulin. At the three-month mark, the data
indicated a 10% increase in blood insulin in patients administered
the genetic treatment with no reported major side effects. At the
six-month marker, a further increase of 72% in blood insulin was
observed. At 12-months-post, the blood insulin concentrations were
nearly fully restored (95% increase) and remained stable for the
subsequent 2, 3, 4, 5 years. No major side effects were reported at
the subsequent time points. Question: What is the major issue with
the implementation of this study? Elaborate.