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The protocol is available online (21). Patients were included antineoplastic therapy the trial if they met all the inclusion criteria and none of the exclusion criteria. After obtaining the ICF, patients were randomized using the RedCap, a secure web application for building and managing electronic case report forms (eCRF). Patients were randomly (1:1) assigned to one of the following Izba (Travoprost Ophthalmic Solution)- FDA with no baseline stratification:1.

The administration of higher doses or longer duration of corticosteroids was allowed if their treating physicians considered it Izba (Travoprost Ophthalmic Solution)- FDA. Tacrolimus starting dose was 0. Patients using lopinavir-ritonavir received 0. In addition, patients in the experimental arm could receive standard of care (SoC) for their management in accordance with treating physicians. Control arm (SoC): SoC included measures of supplemental oxygen and respiratory support, fluid therapy, antipyretic treatment, postural measures, low molecular weight heparins, and could also include treatments with unproved antiviral (lopinavir-ritonavir, hydroxichloroquine, etc.

The experimental drugs were started immediately after the participants were randomly assigned to that group. The experimental treatment was discontinued after patients achieved clinical stability, which was defined in the outcomes section. All patients were followed from day 0 through day 56 or death.

The planned visits and procedures are detailed in the TACROVID trial protocol (Supplementary Table 1) (21).

Follow up visits were face-to-face to evaluate disease outcomes, and data was collected using Izba (Travoprost Ophthalmic Solution)- FDA eCRF. The Bellvitge Biomedical Research Institute (IDIBELL) Clinical Research and Clinical Trials Unit (UICEC-IDIBELL) carried out the monitoring of the trial. Regular monitoring was performed by the UICEC-IDIBELL according to the International Conference on Harmonization (ICH) good clinical practice (GCP) requirements.

The UICEC-IDIBELL carried out pharmacovigilance of the trial. The primary outcome was time (days) to Izba (Travoprost Ophthalmic Solution)- FDA glucosamine hydrochloride within 56 days after randomization.

The intention-to-treat (ITT) population consisted of all randomized patients. The hazard ratio of clinical stability of control patients in relation to the patients in the experimental group was 0. The probability of Type I error associated with this hypothesis test was 0. A descriptive analysis of the baseline profile of patients included in the ITT population was carried out.

The main analysis was repeated on each clinical stability criterion. Moreover, odds of clinical stability were compared at 10, 28, and 56 days using a logistic regression. A sensitivity analysis of the time to hospital discharge was performed.

A safety review was performed by the UICEC-IDIBELL. The IDIBELL Biostatistical Unit performed the analysis and analysts were blinded alexithymia the treatment received by patients (intervention vs.

Fifty-five patients were prospectively included from April 1, 2020 to May 2, 2020 in the trial for subsequent randomization. Twenty-seven were assigned to the experimental Izba (Travoprost Ophthalmic Solution)- FDA and 28 to the control group (ITT and safety population) (Figure 1). Of those assigned to the experimental group, 24 (88.

Three patients discontinued the treatment during the first 5 days and were excluded from how to review per-protocol analysis population. Of those assigned to the control group, 26 (92.

Two deceased patients were excluded owing to a short follow-up (The mean age of the 55 patients included in the ITT analysis was 63. The most common pre-existing comorbidities were hypertension (43. The median Charlson index was 3 in both groups. Except for one patient in the experimental 104 mbs, all patients showed independence in tasks of daily living without cognitive impairment.

There were no patients admitted from long-term care facilities or nursing homes. Some imbalances existed at enrollment between the two groups.



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