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Figure 1.

Flow of participants in the trial (according to CONSORT statement).

* with respect to primary outcome criterion HbA1c.

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Table 1.

Characteristics of the patients.

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Table 1 Expand

Table 2.

Characteristics of the patients.

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Table 2 Expand

Table 3.

Assessment of compliance.

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Table 4.

Outcome and Safety.

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