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Patients who fulfilled the baseline eligibility criteria were randomized 1 1 to receive BOS (2.0 mL/10 mL) or placebo (10 mL) twice daily for 12 weeks, during which they were asked to complete the DSQ once per day.
Baseline eligibility data will be required before randomisation.
Baseline eligibility for each of the 28 CDPS actions is presented in Table 2.
In addition, the study population needed to meet baseline eligibility criteria, which excluded many conditions that may increase bleeding risks.
One hundred and forty-nine patients were included in this study on the basis of baseline eligibility and complete blood sample collection.
Nine domains were assessed: randomization, concealment of treatment allocation, similarity of groups at baseline, eligibility criteria, blinding of outcome assessor, patient and care provider, avoidance of co interventions and intention-to-treat analysis (Table 3).
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Baseline characteristics, eligibility criteria, primary outcome and serious adverse events reported in the CRF were systematically checked against original chart for all research participants.
At the baseline visit, eligibility will be re-confirmed in addition to randomization and beginning of treatment in the evening.
At baseline, study eligibility (Table 1) will be checked and inform consent will be obtained before the recruited participants complete the 'Initial Pharmacy Visit' questionnaires.
In this short trial, hip BMD is not expected to show statistically significant changes, but is being measured at baseline for eligibility determination, and at 9 months to estimate an effect size for a future study.
The DMC gave recommendations on study conduct after the review of the extensive report about the interim analysis including data on patient recruitment, baseline characteristics, eligibility violations, treatment compliance, compliance with planned visits, completeness of follow-up, and safety separately for the different treatment arms.
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