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The dosing algorithm described above applied only to the maintenance phase of the study.
All three events occurred during the bevacizumab maintenance phase of the study in the context of persistent esophagitis.
Because all MAC patients were offered open BT at week 8 on ethical grounds, no data on MAC are available through the maintenance phase of the study.
A total of 327 participants completed dose titration, entered the maintenance phase of the study, and had evaluable maintenance-phase data; 191 participants completed the trial.
During the study, 22% developed ADRs entering the titration phase, 81% during the titration phase, and 45% during the maintenance phase of the study.
In the long-term study, percentages of participants losing clinical response or symptomatic remission at any point during the maintenance phase of the study were calculated from the start date of the study.
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Separate baseline, efficacy, and safety analyses will be done for the induction and maintenance phases of the study.
An important unanswered question the long-term durability of starter insulin therapy is being evaluated in the ongoing 2-year maintenance phase of the DURABLE study.
Ten subjects entered the maintenance phase of this study.
Patients' remission rates, stratified by the treatment received in the parent studies, are shown in table 3. Eighty-nine patienteredtheed the maintenance phase of this study who were not in strictly defined clinical and endoscopic remission at baseline, but who were considered to be well enough by their treating doctor.
Most adverse events reported in this study occurred during the maintenance phase of the treatment period (Table 8).
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