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One control patient withdrew after random selection but before receiving any study treatment because of a latex allergy.
Thirty-one patients were entered into the phase II study, but one patient had disease progression and died before receiving any study therapy.
22 Nonetheless, when a modified ITT (mITT) analysis was performed that excluded three patients who were randomized but discontinued study participation before receiving any study treatment, the primary endpoint was achieved.
From Jan 2007 until March 2008, 49 patients were enrolled in the study; 7 patients (4 patients in group E and 3 patients in group A) were withdrawn before receiving any study medication because of failed spinal anesthesia. 2 patients in group E were excluded from the trial after randomization owing to an overdose of morphine and failed catheter replacement.
The study period was eight weeks in length, during which subjects were assessed at 10 different time points: at the initial interview before receiving any study medication, on study medication day three, on study medication day seven, and once a week thereafter for a total of eight weeks.
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All eligible participants provided written informed consent before undergoing any study procedure or receiving any study treatment.
The study completion rates were relatively low, especially in the sham group, because of the MEAD study design requirement for patients to exit the study before receiving any escape therapy [ 21].
One patient in the placebo injection with physiotherapy group withdrew from the study before receiving any treatment.
Seven patients (Group A, n = 2; Group B, n = 5) were excluded from the safety and efficacy analysis as they withdrew from the study before receiving any dosing of eltrombopag or placebo, 19 (Group A, n = 9; Group B, n = 10) received eltrombopag 100 mg, and seven (Group A, n = 3; Group B, n = 4) received matching placebo.
Fourteen subjects dropped out for personal nonmedical reasons before receiving any insulin as part of this study: 8 subjects assigned to glulisine and 6 subjects assigned to regular insulin.
Ethylenediaminetetraacetic acid (EDTA) plasma samples were collected at baseline before patients received any study medication and immediately frozen at −80°C for storage.
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before receiving any escape
before receiving any medication
before receiving any kind
before receiving any training
before receiving any money
before receiving any care
before receiving any offer
before commencing any study
before receiving any word
before undertaking any study
before receiving any vaccination
before receiving any endocrine
before receiving any equipment
before receiving any chemotherapy
before receiving any form
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