Exact(4)
The initial "blind" dose of orally given iron (e.g. Ferrosanol® capsules 100 mg) was about 100 mg/30 kg b.i.d. or about 100 mg/10 kg weight Ursoferran i.m. two times a week.
During the course of the study there were three double blind dose equivalence studies, comparing then new ESAs with EPO.
This is a monocenter, placebo controlled, double blind dose escalation study of the experimental vaccine VXM01 in patients with advanced inoperable or stage IV pancreatic cancer.
In the absence of routine anti-factor Xa activity assays, some caution may be required before instituting blind dose increases for a group of patients who are at risk of occult bleeding and for a drug with effects that are difficult to reverse.
Similar(56)
The randomized, placebo-controlled, double blind dose-escalation study includes up to 45 patients with locally advanced and stage IV pancreatic cancer.
Randomization was performed at the beginning of the double- blind dose-confirmation phase and the double- blind maintenance of effect phase upon fulfillment of the inclusion/exclusion criteria mentioned above.
The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial was to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (OA).
Of the 725 patients randomized at phase 1 baseline, 584 (80.6%) patients completed the 9-week doublindblindose-confirmationon phase and entered the real- life dose-optimization phase.
The key secondary endpoint was the proportion of patients with clinical improvement at the end of the initial double- blind dose-confirmation phase on the physician-rated Clinical Global Impression-Improvement Scale (CGI-I) [ 17].
AEs were more frequently observed in each of the MPH-LA-treated groups compared to placebo during the double- blind dose-confirmation phase and the 6-month double- blind maintenance of effect phase (Table 5).
During the 9-week doublindblindose-confirmationon phase, anxiety and decreased appetite each led to discontinuation in 2.2% of patients in the MPH-LA 60 and 80 mg groups, respectively.
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